J&J's once-daily pill eases psoriatic arthritis symptoms in late-stage trial
A once-daily oral pill from Johnson & Johnson eased psoriatic arthritis symptoms in a late-stage trial, Reuters reports.
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963 intelligence updates indexedCVS to split into two companies in stunning strategic about-face
The breakup, which will separate Aetna and Caremark from CVS' retail pharmacies, is an indictment of the dogma that bigger is always better in the healthcare industry.
Eli Lilly forces compounding rival to shed weight loss claims
Eli Lilly has forced a compounding rival to drop weight loss claims, Fierce Pharma reports.
Forge’s Piteri-Molina on AI, Ohio and what’s next for gene therapy manufacturing
The BioSpace 40 Under 40 honoree helped steer Forge’s sale to Ajinomoto. Now, Samantha Piteri-Molina sees opportunities in AI-driven analytics and Ohio’s gene therapy ecosystem—with a responsibility to patients worldwide.
Inflammation-focused Rezera sets terms for IPO
Rezera, formerly known as NodThera, has announced the terms of its planned IPO, hoping to raise upwards of $200m for its NLRP3 inhibitor pipeline.
Keytruda biosimilars are coming — but they face an uphill battle
A patent cliff is fast approaching for Merck's flagship blockbuster, but the deck might be stacked against its biosimilars gaining widespread traction.
Sarepta’s new CEO confident in clinical execution as DMD competitors close in
Sarepta Therapeutics’ newly minted CEO Michael Severino laid out his path to returning the muscular dystrophy therapy maker to the forefront of the rapidly expanding market.
UK pilots shorter NICE appraisal for new medicines
NICE and NHS England are piloting a shorter initial assessment process for promising new medicines, aiming to slash times from 12 to six months.
Akebia Therapeutics Discloses 7% Workforce Reduction in Q3 10-Q Filing to Streamline Operations
Akebia Therapeutics disclosed in its Q3 2026 Form 10-Q an implemented 7% workforce reduction (~14 positions) and $1.3M in restructuring expenses to focus capital on Vafseo and Auryxia commercial execution.
Novartis Subsidiary Avidity Biosciences Cuts 40 Roles in San Diego Following Phase 3 Impairment
Avidity Biosciences filed a California WARN Act notice disclosing permanent layoffs for 40 employees (~8% of staff) in San Diego on a rolling basis beginning December 31, 2026, following parent Novartis' $1.9B impairment charge on lead DM1 asset del-desiran.
Boehringer bets big on China, offering $7B biobucks for Sino cancer programs
Boehringer Ingelheim is building up its China strategy, inking a deal to develop new cancer treatments with Sino Biopharmaceutical just weeks after opening an R&D facility in Shanghai.
Cash-strapped Vivoryon regains China rights to kidney prospect
Cash-strapped Vivoryon regains China rights to kidney prospect
Coveted metabolic gem Rhythm reportedly gets $10B offer from AstraZeneca
AstraZeneca has apparently made a $10 billion bid to acquire Rhythm Pharmaceuticals, an offer William Blair suspects will not be the last for the hot ticket metabolic biotech.
Evommune inks molecular glue deal worth $1.1B biobucks to fill pipeline gap
Evommune is commiting $30 million upfront for Hinova Pharmaceuticals’ oral molecular glue degrader—a low-cost bet with a high probability of success, according to analysts, after clinical failures roiled the biotech’s internal pipeline earlier this year.
Rezera revs up for $181M IPO to fund NLRP3 inhibitor ph. 3 trial
Rezera—the new name for NodThera—is aiming for a $181 million IPO to take
UK backs start-up Potential Sciences' AI-powered drug hunt
UK start-up Potential Sciences emerged from stealth today with a sizeable seed funding round and an ambition to transform drug discovery with AI.
UK biotechs T-Therapeutics and Alethio score big financings
Two up-and-coming UK biotechs – T-Therapeutics and Alethio Therapeutics – have raised $133m and $90m, respectively, in impressive financing rounds.
Vanda drives straight into FDA trouble with fast-paced Nereus ad
Vanda Pharmaceuticals’ action-packed TV ad for motion-sickness drug Nereus has irked the FDA, which accused (PDF) t
Novo aims for deals to ‘close some gaps’ as misfires hit profits
Novo aims for deals to ‘close some gaps’ as misfires hit profits
nPhase rakes in $30M to expand AI-native clinical data platform
nPhase rakes in $30M to expand AI-native clinical data platform
Servier’s $1.6B muscular dystrophy bet fails pivotal test
Servier’s $1.6B muscular dystrophy bet fails pivotal test
Aspen raises a $141M IPO in pursuit of a cell therapy for Parkinson's
Aspen raises a $141M IPO in pursuit of a cell therapy for Parkinson's
EVERSANA builds its AI Agency with Estima acquisition
EVERSANA builds its AI Agency with Estima acquisition
Novartis puts $772M BioArctic deal on ice, skates away from brain-delivery alliance
Novartis puts $772M BioArctic deal on ice, skates away from brain-delivery alliance
Drugmakers rush to pair up with Summit’s ivonescimab ahead of key verdict
Drugmakers rush to pair up with Summit’s ivonescimab ahead of key verdict
UniQure gets an FDA decision date; Teva scraps brain drug study
The FDA appears likely to hold an advisory committee for UniQure’s closely watched Huntington’s disease gene therapy. Elsewhere, a biotech’s share price was cut in half following a regulatory setback.
Bispecific J&J Drug Wins Speedy FDA Approval for Treating Head & Neck Cancer
Accelerated FDA approval of Johnson & Johnson’s Rybrevant Faspro covers advanced cases of head and neck cancer. The bispecific antibody was initially approved for treating certain lung cancers.
AstraZeneca Initiates Collective Redundancy Process in Spain Affecting Roughly 200 Roles
AstraZeneca opened a formal collective redundancy procedure (ERE) in Spain affecting approximately 200 commercial and administrative positions, aligning local commercial operations with its evolving oncology and specialty biopharma portfolio.
AbbVie’s Q3 beat should keep ‘train rolling’ as company eyes bolt-on deals
AbbVie’s Q3 beat should keep ‘train rolling’ as company eyes bolt-on deals
Acumen scraps sole asset after Alzheimer’s fail, plunging stock 80%
Acumen scraps sole asset after Alzheimer’s fail, plunging stock 80%
Lilly can't stop, won't stop as revenue climbs 39% thanks to GLP-1 bestsellers
Eli Lilly reported a 39% jump in quarterly revenue, powered by demand for its GLP-1 franchise, as the company again raised expectations for the year.
Ono cans 2 endocannabinoid drug studies after quintuple Phase 2 failure
Ono cans 2 endocannabinoid drug studies after quintuple Phase 2 failure
Women 'still waiting' to trust healthcare institutions: report
Women 'still waiting' to trust healthcare institutions: report
Clarius Leads Handheld Ultrasound AI with Industry's Largest Integrated Portfolio of 30 Models
Clarius Leads Handheld Ultrasound AI with Industry's Largest Integrated Portfolio of 30 Models
Teva to Shutter 'Underutilized' New Jersey Plant, Slashing 61 Manufacturing Jobs via NJ WARN Filing
Teva Pharmaceutical Industries filed a New Jersey WARN Act notice disclosing 61 layoffs and the permanent closure of its solid oral-dose manufacturing facility in Fairfield, NJ by January 31, 2027, as part of CEO Richard Francis's 'Pivot to Growth' cost-efficiency strategy.
Novartis faces $1.9B hit from Avidity fail but maintains confidence in $12B buy
Novartis faces $1.9B hit from Avidity fail but maintains confidence in $12B buy
Vincora Receives FDA Approval to Initiate U.S. Early Feasibility Study of Transcatheter Chordal Repair System
Vincora Receives FDA Approval to Initiate U.S. Early Feasibility Study of Transcatheter Chordal Repair System
ESMO: Tango Therapeutics Cuts 14% of Workforce to Fund Phase 3 PRMT5 Push and RevMed Combo
Boston-based Tango Therapeutics laid off 14% of its staff (~19 discovery roles) to halt novel target discovery and concentrate capital on its clinical PRMT5 inhibitors vopimetostat and TNG456 after reporting strong Phase 1/2 pancreatic cancer combination data with Revolution Medicines.
Australia’s clinical trial advantage gains ground amid U.S. uncertainty
Australia’s clinical trial advantage gains ground amid U.S. uncertainty
US biotechs take lion’s share of $54.5B VC money raised since 2025
US biotechs take lion’s share of $54.5B VC money raised since 2025
Australia's CSL names interim CEO Gordon Naylor as new chair
Australia's CSL names interim CEO Gordon Naylor as new chair
Coreline Soft Receives U.S. FDA 510(k) Clearance for AVIEW Aorta Metrics, Expanding Its Chest CT AI Portfolio in the U.S.
Coreline Soft Receives U.S. FDA 510(k) Clearance for AVIEW Aorta Metrics, Expanding Its Chest CT AI Portfolio in the U.S.
Fractyl Health Cuts 45% of Workforce and Shelves Rejuva Gene Therapy to Focus on Revita De Novo Filing
Burlington, Massachusetts-based Fractyl Health is laying off approximately 45% of its staff (~45 roles) and discontinuing internal development of its Rejuva pancreatic gene therapy program to focus resources on an FDA De Novo marketing submission for its Revita post-GLP-1 weight maintenance procedure.
FDA grants 510(k) clearance for BoneEnhance, the first machine learning layer on RIVANNA's Accuro XV platform
FDA grants 510(k) clearance for BoneEnhance, the first machine learning layer on RIVANNA's Accuro XV platform
Astellas links up with AI Proteins in $400M drug discovery deal
Astellas links up with AI Proteins in $400M drug discovery deal
FDA accuses Baxter leaders of ‘inadequate’ oversight after finding GMP failings
FDA accuses Baxter leaders of ‘inadequate’ oversight after finding GMP failings
Roche’s pipeline trim claims Poseida’s off-the-shelf CAR T asset
Roche’s pipeline trim claims Poseida’s off-the-shelf CAR T asset
AI tool uses face photos to predict cancer survival
AI tool uses face photos to predict cancer survival
AZ and Oracle team up on AI platform for clinical trials
AZ and Oracle team up on AI platform for clinical trials
Lilly puts $1.1B on the line for Hong Kong biotech’s AI drug delivery platform
Lilly puts $1.1B on the line for Hong Kong biotech’s AI drug delivery platform
Nano24’s exosome therapy reduces respiratory failure in ph. 2
Nano24’s exosome therapy reduces respiratory failure in ph. 2
Xylyx Bio announces FDA Orphan Drug Designation and $2.99M NIH SBIR grant award for its lead organ graft product, Inspirex™ Lung
Xylyx Bio announces FDA Orphan Drug Designation and $2.99M NIH SBIR grant award for its lead organ graft product, Inspirex™ Lung
Experimental Arrowhead RNAi drug hints at Alzheimer's benefit
Experimental Arrowhead RNAi drug hints at Alzheimer's benefit
EyePoint to halve workforce after experimental drug fails second late-stage trial
EyePoint to halve workforce after experimental drug fails second late-stage trial
EyePoint will halve workforce, end pivotal wet AMD trials early following second fail
EyePoint will halve workforce, end pivotal wet AMD trials early following second fail
FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
Lilly allies with Metis in $1.1B AI nanoparticle discovery deal
Eli Lilly has formed a partnership with Hong Kong's Metis TechBio worth up to $1.1 billion, gaining access to an AI drug delivery platform
Next-gen RNAi drugmaker City prices $200M IPO
Next-gen RNAi drugmaker City prices $200M IPO
Novavax critic Shah Capital ends its activism campaign
Shah Capital has ended attempts to exert influence over vaccine firm Novavax, bringing more than years of pressure on management to an end.
Protego Announces FDA IND Clearance for Phase 2/3 Study of PROT-001 in AL Amyloidosis
Protego Biopharma said the FDA has cleared its IND for a Phase 2/3 study of PROT-001, a small-molecule pharmacological chaperone designed to stabilize amyloidogenic light-chain proteins, in AL amyloidosis.
Roivant, continuing ascent, claims another victory for rare disease drug
Roivant, continuing ascent, claims another victory for rare disease drug
Servier Announces First Patients Dosed in Pivotal Phase 2 EMBLEM-1 Cohort Evaluating Emiltatug Ledadotin (Emi-Le) in Adenoid Cystic Carcinoma
Servier said the first patients have been dosed in the pivotal Phase 2 EMBLEM-1 cohort of its Phase 1/2 study of Emiltatug Ledadotin (Emi-Le) in adenoid cystic carcinoma.
UK Biobank partners with industry on 'most detailed' immune ...
The UK Biobank has teamed up with industry partners to create 'the world’s most detailed, large-scale picture of the human immune system.'
RNAi biotech City hauls in $200m in upsized IPO
City Therapeutics has finalised its IPO, raising $200 million for a pipeline of RNA interference therapies headed by a novel anticoagulant.
City’s IPO soars to $200M, with proceeds supporting thromboembolic disease pipeline
City Therapeutics will join a slew of biotechs that have entered the public markets this year, with a $200 million raise that landed above expectations.
Estuary sails into kidney disease space with $103M for gene therapies
Estuary Biotherapeutics is seeking to address the root cause of autosomal dominant polycystic kidney disease with two gene therapy programs based on science from Yale.
FDA clears Roche's Enspryng for thyroid eye disease
Roche has claimed US approval for Enspryng in a second indication, thyroid eye disease, that makes it a rival to drugs from Amgen and Viridian.
Iambic, an AI drug discovery specialist, banks $150M in an IPO
Part of a wave of young biotechs employing AI to accelerate research, the company claimed in regulatory filings that its approach has the potential to “disrupt legacy drug discovery paradigms.”
Roche adds another obesity drug with $1.16bn Rona deal
Roche has added to its weight-loss pipeline again, licensing an RNAi candidate targeting ALK7 from China's Rona Therapeutics in a deal worth up to $1.16 billion.
Sobi receives positive CHMP opinion for Tryngolza (olezarsen) for the treatment of severe hypertriglyceridemia (sHTG)
Sobi said the EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for Tryngolza (olezarsen) in severe hypertriglyceridemia, clearing the way for an EU decision.
UCB announces U.S. FDA approval for ZILBRYSQ® (zilucoplan) autoinjector self-administration for adults living with generalized myasthenia gravis
The FDA approved a self-administered once-daily subcutaneous autoinjector formulation of Zilbrysq (zilucoplan) for adults living with generalized myasthenia gravis.
Viatris Receives U.S. FDA Approval for RYZUMVI for the Treatment of Presbyopia
Viatris said the U.S. Food and Drug Administration approved RYZUMVI for the treatment of presbyopia, according to the company's announcement.
Another Paragon spinout goes public through reverse merger
Another Paragon Therapeutics spinout is heading for the public markets through a reverse merger, the latest such exit for the cell therapy incubator and key backer Fairmount.
AstraZeneca, insitro ink $1.5B AI-enabled target discovery deal
AstraZeneca will pay insitro $40 million upfront in a deal worth up to $1.5 billion to apply the AI drug discovery company's platform to MASH and cardiomyopathies.
Lilly says it's setting 'higher bar' in IBD with Omvoh post-hoc
In the fiercely competitive inflammatory bowel disease (IBD) market, Eli Lilly is making the case for its antibody Omvoh as a holistic solution for patients living with ulcerative colitis or Crohn's disease, and one that could offer relief after other biologic drugs have failed.
Merck and Moderna have ‘lot of exploring to do’ after initial cancer vaccine success
Speaking at the STAT Summit, Stephen Hoge and Dean Li described how Merck and Moderna will pair Keytruda with personalized mRNA vaccines to target tumors.
OMass’ $310M raise fuels goal to become ‘Britain’s Big Biotech’
OMass Therapeutics raised a $310 million Series C to push its small-molecule pipeline in endocrinology and immunology toward the clinic, part of a stated ambition to become 'Britain's Big Biotech.'
OrbiMed’s largest-ever Asian fund contributes to $3B war chest
OrbiMed raised $3 billion across new life sciences funds, including its largest-ever Asia-focused vehicle.
Par Health recalls 22 lots of potentially tainted IV bags
US generic drugmaker Par Health recalled 22 lots of an IV blood thinner after finding potentially tainted product, its third recall in a month.
Roche breast cancer drug Itovebi turned down by NICE
NICE turned down NHS use of Roche's breast cancer drug Itovebi, which the company says reveals a flaw in the appraisal of combination therapies.
Roche extends China deal streak with $1B pact for RNAi obesity drug
An alliance with Rona Therapeutics adds to a particularly active stretch for Roche and makes the company the latest to bet on medicines that can lower levels of “visceral” fat.
SimBioSys Secures FDA Clearance for TumorSight® Risk, Introducing the World's First AI-Powered, MRI-Derived Breast Cancer Recurrence Risk Assessment
SimBioSys said the FDA cleared TumorSight Risk, which the company describes as the first AI-powered, MRI-derived breast cancer recurrence risk assessment.
Vanda pauses social anxiety program after failing phase 3 trial
Vanda Pharmaceuticals paused its social anxiety program after the ex-Novartis asset failed a Phase 3 trial.
Alnylam bulls and bears fight it out after business-shaking guidance cut
While Alnylam’s recent reduced revenue guidance spooked investors, analysts remain broadly bullish on the biotech’s commercial prospects.
Arrowhead’s blood-brain barrier tech is ‘arguably better’ than others, analysts say after data drop
Arrowhead Pharmaceuticals' siRNA candidate achieved 'compelling' tau reductions in an early study of healthy volunteers, a magnitude of effect that appears to outperform other blood-brain barrier platforms, according to analysts.
Biomea posts phase 1 data to pitch oral GLP-1 to potential partners, but investors appear unconvinced
Biomea Fusion has shared phase 1 data on its oral GLP-1 prospect, shedding light on a small molecule designed to balance efficacy and gastrointestinal tolerability. Management hailed the data as a launchpad for talks with potential partners, but investors drove down the share price of the cash-str.
European biotech leaders split on US-China fight for deal dominance, survey finds
While industry leaders are unsure whether the U.S. or China will prevail, they are largely united in the belief that Europe is lagging behind.
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
The FDA expanded approval of Anktiva (nogapendekin alfa inbakicept-pmln), given with BCG, to adults with BCG-unresponsive, high-grade papillary-only bladder cancer - the first FDA-approved treatment specifically for that population.
FDA approves Gore’s Viabahn VBX endoprosthesis for expanded use in FEVAR and BEVAR
W. L. Gore & Associates said the FDA has approved an expanded indication for its GORE VIABAHN VBX balloon expandable endoprosthesis, clearing its use in FEVAR and BEVAR procedures.
FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development
The FDA launched the Rare Disease Framework Initiative to reimagine development of drugs and biologics for rare diseases, aiming at a holistic, fit-for-purpose framework for sponsors.
Gilead snags equity stake in Vir with up to $1.87B deal for three T cell engagers
The Gilead Sciences deal, which includes $135 million in upfront and near-term payments, marks a critical platform validation for Vir Biotechnology as investors await an upcoming readout in solid tumors.
GSK plans 1.2K+ layoffs at Belgium sites as $2.5B restructure gains momentum
The layoffs across GSK's Belgium sites come on the heels of the pharma's planned shuttering of its German vaccine manufacturing site, which prompted job cuts for about 650 employees.
MHRA lays out its thinking on AI and medicines regulation
An MHRA document explaining how regulations will adapt to the era of AI and personalised medicine has been well received by the pharma industry.
Pierre Fabre Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for Tabelecleucel for the Treatment of Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative Disease
Pierre Fabre said the FDA accepted its resubmitted biologics license application for tabelecleucel in Epstein-Barr virus-positive post-transplant lymphoproliferative disease.
Ultragenyx cashes in a pair of FDA review vouchers for $413M
Ultragenyx sold a pair of FDA rare disease review vouchers for $413 million following its summer gene therapy approvals.
Zealand pens up to $1.2B deal with Generate for AI-designed obesity, metabolic drugs
Obesity-focused Zealand Pharma is buying into Generate:Biomedicines's generative AI platform to create new multispecific drug candidates.
BioNTech’s mRNA cancer vaccine fails phase 3 test
BioNTech's mRNA-based cancer vaccine has failed a Phase 3 test in head and neck cancer, denting confidence in the company's lead therapeutic cancer vaccine program as it looks beyond COVID-19.
First Tracks climbs on ‘impressive’ celiac study data
Initial study findings strengthened some analysts' belief that First Tracks' drug, one of a few in development aimed at the protein CD122, might have “pipeline-in-a-product” potential.
Helen Branswell, whose reporting on infectious diseases and public health drew acclaim, dies at 69
Helen Branswell, whose reporting on infectious diseases and public health drew acclaim, dies at 69
Nurix drops BTK degrader, as Roche-partnered asset enters ph. 3
Nurix Therapeutics is discontinuing one of its BTK-targeted programs while momentum builds behind a partnered asset that is moving into Phase 3, sharpening the company's focus on its remaining degraders.
Roche expands obesity R&D footprint with Rona deal worth $1B+
Roche has added another obesity drug candidate, licensing an asset from China-based RNAi developer Rona Therapeutics in a deal valued at roughly $1.16 billion. It is the latest in a string of China-focused licensing pacts for the Swiss pharma as it builds out its metabolic pipeline.
Syndax ends fibrosis program for Niktimvo after mid-stage disappointment
Syndax Pharmaceuticals is ending development of its drug Niktimvo in lung fibrosis after a mid-stage study failed to deliver, a setback for the company's effort to widen the therapy beyond its approved uses.
Asahi Kasei makes good on AiCuris buyout with new FDA nod
The FDA approved Asahi Kasei's pritelivir, to be sold as Hovilpri, for HSV-caused mucocutaneous lesions in immunocompromised adults refractory to standard nucleoside analogues — the first new mechanism for HSV treatment in nearly three decades.
Bausch + Lomb CEO Brent Saunders hits the exit again
Bausch + Lomb is replacing chief executive Brent Saunders, who is leaving the eye-care company for a second time, and has named an interim successor to lead the business.
Bristol Myers dips on 'confounding' lung drug results
Only the lower of two tested doses of the idiopathic pulmonary fibrosis drug admilparant met the trial's main objective, adding to analyst questions about the therapy's prospects.
Merck data raise fears $1.3B eye drug has 'limited' potential
Full Brunello trial data for Merck's trispecific remigromig showed undifferentiated efficacy and concerning safety signals in diabetic macular edema, leading analysts to predict "limited competitive potential" for the $1.3 billion Eyebiotech asset.
T-MAXIMUM's B7-H3-targeted allogeneic CAR-T MT027 receives FDA clearance for phase 2 study in brain metastases
T-MAXIMUM's allogeneic CAR-T MT027, which targets B7-H3, has received FDA clearance to begin a phase 2 study in brain metastases from lung and breast cancer.
Americans trust science more than peers around the world, survey shows
A new Wellcome Global Monitor survey of people in 140 countries finds 52% of Americans report having "a lot" of trust in science, versus 26% globally. STAT's analysis of the data shows the U.S. remains far more divided than peer nations along religious, geographic and educational lines.
Arcutis' Zoryve sticks the landing with gymnast Simone Biles in new awareness campaign
Arcutis Biotherapeutics has added Olympic gymnast Simone Biles to its roster of celebrity spokespeople for the topical skin medicine Zoryve, fronting a "Skin to Believe In" campaign aimed at the roughly 36 million people in the U.S. living with inflammatory skin conditions.
Click claims FDA okay for first-in-class schizophrenia DTx
Click claims FDA okay for first-in-class schizophrenia DTx
GSK drinks in Chai’s AI models after wet-lab validation
GSK drinks in Chai’s AI models after wet-lab validation
Halozyme prevails in patent fight with Merck; Enliven readies anticipated leukemia trial
Halozyme prevails in patent fight with Merck; Enliven readies anticipated leukemia trial
Quince, now IRulya, debuts new name, focus and leadership
Quince Therapeutics has relaunched as IRulya Therapeutics, rebranding around an inhaled pulmonary-disease pipeline following its merger with Orphai Therapeutics, alongside a new C-suite and a move of its Nasdaq listing.
Alpheus Medical opens enrollment in new clinical trial for butterfly glioblastoma
Alpheus Medical has opened enrollment in a clinical trial evaluating its sonodynamic therapy in butterfly glioblastoma.
Iambic aims for $135M IPO to push cancer drugs through clinic
AI drug-discovery company Iambic Therapeutics is aiming for a $135 million IPO to advance its cancer programs into the clinic.
Newron reveals 5 deaths in late-stage schizophrenia program as FDA maintains hold
Newron Pharmaceuticals disclosed five deaths in the late-stage trial of its schizophrenia program as an FDA clinical hold remains in place.
Saol Therapeutics announces completion of enrollment in pivotal Phase III BEACON trial of SL1002 for chronic pain related to knee osteoarthritis
Saol Therapeutics has completed patient enrollment in the pivotal Phase III BEACON trial of SL1002 in chronic pain associated with knee osteoarthritis.
Viatris builds in pain relief with $1.65bn Pacira purchase
Viatris is acquiring Pacira BioSciences in a $1.65 billion deal that adds non-opioid pain-management products to its portfolio.
Wellysis secures FDA 510(k) clearance for AI-powered ECG analysis software, S-Patch CardioAI
Wellysis has received FDA 510(k) clearance for S-Patch CardioAI, an AI-powered ECG analysis software.
2026 Nobel Prize in chemistry awarded for ‘mirror image’ molecule research, with impact on pharmacology
The 2026 Nobel Prize in Chemistry was awarded for research on 'mirror image' molecules, work with direct implications for pharmacology and drug design.
5 biggest venture capital raises of Q3 2026
A look at the five largest venture capital raises in biopharma during the third quarter of 2026.
AI companies run virtual drug trials, aim to improve success of human studies
AI companies run virtual drug trials, aim to improve success of human studies
Experimental approach uses AI to eliminate cold storage for mRNA vaccines
Experimental approach uses AI to eliminate cold storage for mRNA vaccines
Matchpoint nets $150M series B to take covalent med into clinic
Matchpoint Therapeutics raised a $150M Series B to take its covalent medicine into the clinic.
An AI agent made a tiny drug R&D mistake. Then it kept going.
The error points to a big question for pharma as AI gains autonomy and high-profile failures sharpen safety concerns: What happens when a wrong answer becomes the basis for the next decision?
Cala Announces Nationwide Launch of its Next Generation TAPS Therapy Wearable for Essential Tremor and Parkinson's Disease Further Optimizing Meaningful Outcomes for More Patients
/PRNewswire/ -- Cala®, the bioelectronic medicine leader, today announced nationwide availability of the Cala kIQ® Plus System, the latest advancement of its...
Enliven Therapeutics Announces FDA Alignment on ENABLE-2 Phase 3 Trial Design for Relcobatinib (ELVN-001) in Previously Treated Chronic Myeloid Leukemia
Enliven Therapeutics said the FDA aligned on the ENABLE-2 Phase 3 trial design for relcobatinib (ELVN-001) in previously treated chronic myeloid leukemia.
Fierce Biotech Fundraising Tracker '26:KymaThera, RougeTx & more
Fierce Biotech Fundraising Tracker '26:KymaThera, RougeTx & more.
Forbion's 'landmark' €2.3B fundraise to benefit 30 biotechs
Forbion's 'landmark' €2.3B fundraise to benefit 30 biotechs.
Kairos seizes moment to push cancer asset into earlier setting
Kairos seizes moment to push cancer asset into earlier setting.
Mimetic's peptide shows promise in reducing neuropathic pain
While psychedelic drugs may be capturing all the attention when it comes to finding fresh ways to treat neuropathic pain, research with mice has suggested a peptide approach may also be effective.
Once-daily RELEXXII® (methylphenidate hydrochloride extended-release tablet) supports Attention Deficit Hyperactivity Disorder (ADHD) Awareness Month
/PRNewswire/ -- October marks ADHD Awareness Month, shining a light on the need for timely diagnosis and personalized treatment. Vertical Pharmaceuticals is...
Shionogi makes $2B rare disease play with IntraBio buy
With its acquisition of IntraBio, Shionogi will gain ownership over Aqneursa, which could hit peak global sales of $1 billion across its two indications in Niemann-Pick disease type C and ataxia-telangiectasia, according to Jefferies.
Three in Four FDA Authorizations of AI Medical Devices Were in Radiology, Study Led by GigHz Founder Finds
/PRNewswire/ -- GigHz, a physician-founded software and research company, today announced findings from a peer-reviewed study led by its founder, Pouyan...
UK backs all health AI proposals in commission report
The UK will accept all 44 proposals made in a recent report on using AI tools in the NHS, including continuous monitoring after deployment.
Abbott receives FDA approval for new CardioMEMS HF System capabilities that help patients engage in the care of their heart condition
Abbott said the FDA has approved new capabilities for its CardioMEMS HF System, an implantable remote-monitoring sensor for heart failure patients designed to help them take a more active role in managing their condition.
AIRS Medical Receives FDA 510(k) Clearance for SwiftSight® Body Composition
/PRNewswire/ -- AIRS Medical today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for SwiftSight® Body Composition,...
BridgeBio gears up for YouTube ATTR-CM awareness push
BridgeBio is turning to YouTube and partnerships with hip-hop and public-health voices for a new campaign aimed at raising awareness of ATTR-CM, the rare heart condition treated by its drug Attruby.
CSL strikes up to $1.6B deal with Alentis for autoimmune drug with broad potential
CSL has agreed to pay up to $1.6 billion to co-develop an Alentis Therapeutics drug for autoimmune disease, pairing the Australian company's commercial reach with a claudin-targeting candidate.
FDA Seeks Public Input to Support Ibogaine Research
The FDA said it is seeking public input as part of an effort to support research into ibogaine, a psychedelic compound being studied for addiction and other psychiatric uses.
Genentech pens $1.27B deal to access Alector's preclinical blood-brain barrier asset
Genentech has signed a deal worth up to $1.27 billion to license a preclinical blood-brain barrier asset from Alector, adding to its neurology pipeline.
HAI Solutions Issued U.S. Patent for RFID-Enabled QIKcap Platform
/PRNewswire/ -- Issued Patent Advances an AI-Enabled Platform for IV Connector CareHAI Solutions, a medical device company focused on intravenous therapy and...
Novo cites production site corrections amid hemophilia FDA delay
Novo Nordisk said its U.S. review of a hemophilia candidate has been extended after the FDA flagged corrections needed at a manufacturing site, pushing back a potential approval decision.
OMLYCLO (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to Xolair, now commercially available in the US
OMLYCLO (omalizumab-igec), described as the first and only FDA-approved interchangeable biosimilar to Xolair, is now commercially available in the United States.
Pfizer's eczema drug clears skin in mid-stage trial
Detailed results are competitive with Dupixent and Ebglyss, but the drug lacks differentiation amid an increasingly competitive landscape, one analyst argued.
Biogen's experimental lupus drug shows benefit against skin symptoms
Biogen's experimental lupus drug showed benefit against skin symptoms, according to the report.
Buzzy AI biotech Xaira unveils antibody platform ambitions
Buzzy AI biotech Xaira unveils antibody platform ambitions
Everlywell rolls out Clairity AI for breast cancer in US
Everlywell rolls out Clairity AI for breast cancer in US
Lilly's Jaypirca (pirtobrutinib), the first-and-only approved non-covalent BTK inhibitor, receives expanded indication from U.S. FDA for certain patients with previously untreated CLL/SLL
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved an additional indication for...
NIH rolling out streamlined website to help public find information more easily
NIH rolling out streamlined website to help public find information more easily
Varda raises $251M to leverage gravity in space for drug production
Capitalizing on space’s microgravity, the United Therapeutics–partnered Varda Space Industries aims to make medicines with better bioavailability and stability than Earth-produced molecules.
BioMarin Expands Again in Enzyme Replacement, Paying $70M for Long-Acting Fabry Drug
BioMarin Expands Again in Enzyme Replacement, Paying $70M for Long-Acting Fabry Drug
Genentech amplifies breast cancer conversations in new campaign
Genentech amplifies breast cancer conversations in new campaign
GORE ANNOUNCES FIRST PATIENT ENROLLMENT IN THE GORE EXCLUDER IBE PLUS STENT GRAFT PIVOTAL STUDY
GORE ANNOUNCES FIRST PATIENT ENROLLMENT IN THE GORE EXCLUDER IBE PLUS STENT GRAFT PIVOTAL STUDY
Immunology Startup ai3Bio Aims to Redefine What It Means to Reset the Immune System
While the immune reset field is mainly focused on depleting pathogenic B cells, ai3Bio is applying its novel approach to inflammatory T cells. The startup’s initial disease targets are autoimmune disorders of the liver that have few treatment options if any at all.
Kailera, Hengrui’s GLP-1/GIP candidate delivers weight, menstrual benefits to women with PMOS
Kailera, Hengrui’s GLP-1/GIP candidate delivers weight, menstrual benefits to women with PMOS
Pfizer Pill's Phase 3 Data in Vitiligo Pave Way for FDA, EMA Submissions
Pfizer’s Litfulo significantly improved skin pigment measures in two pivotal studies in vitiligo, results that were presented during the European Academy of Dermatology and Venereology annual meeting. If Pfizer’s daily pill is approved, it would compete against an Incyte topical cream that is...
Real Chemistry adds MaestroHCP to conduct omnichannel campaigns
Real Chemistry adds MaestroHCP to conduct omnichannel campaigns
Taiho ph. 3 win sets up potential oral franchise expansion
Taiho ph. 3 win sets up potential oral franchise expansion
Top journal’s special issue on women’s health casts spotlight on menopause and pain
Top journal’s special issue on women’s health casts spotlight on menopause and pain
US FDA advisers recommend flu vaccine strains for 2027 Southern Hemisphere season
FDA advisers have recommended which flu vaccine strains should be used for the 2027 Southern Hemisphere season.
US government launches AI-driven programs to overhaul clinical trials
US government launches AI-driven programs to overhaul clinical trials
AstraZeneca buys into Summit, UniQure drops on 4-year data, FDA on a roll
Summit Therapeutics scores a $2 billion equity investment from AstraZeneca to support ivonescimab’s late-stage development; uniQure crashes after four-year data from its Huntington’s disease gene therapy failed to impress; Kyverna Therapeutics brings new light to a struggling CAR T space in…
Atara, Pierre Fabre resubmit twice-rebuffed cell therapy after FDA flips again
Atara, Pierre Fabre resubmit twice-rebuffed cell therapy after FDA flips again
Beam sues rival startup, claims former scientist stole secrets
Beam sues rival startup, claims former scientist stole secrets
FIRE1 Announces First Patient Implant in the NORM-HF Pivotal Trial Evaluating a New Physiologic Approach to Heart Failure Management
FIRE1 Announces First Patient Implant in the NORM-HF Pivotal Trial Evaluating a New Physiologic Approach to Heart Failure Management
Lilly raises diabetes weight-loss bar with amylin-Zepbound combo
Lilly raises diabetes weight-loss bar with amylin-Zepbound combo
Organon phones home with sci-fi themed Vtama campaign
Organon phones home with sci-fi themed Vtama campaign
ai3Bio buzzing with $48M for STING pathway targeting pipeline
ai3Bio buzzing with $48M for STING pathway targeting pipeline
Audien beams up William Shatner to boldly boost hearing aid biz
Audien beams up William Shatner to boldly boost hearing aid biz
Beam sues 2 biotechs, alleging theft of base editing trade secrets
Beam claimed a former scientist stole confidential information and quietly spun up a rival rare disease treatment at YolTech Therapeutics. Serapha Bio, which licensed that therapy, denies the charges.
Cepheid Receives FDA Clearance for Xpert® Respiratory Panel to Aid in the Diagnosis of Respiratory Tract Infection
Cepheid Receives FDA Clearance for Xpert® Respiratory Panel to Aid in the Diagnosis of Respiratory Tract Infection
FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
Inizio Evoke names new leaders in media, AI and client accounts
Inizio Evoke names new leaders in media, AI and client accounts
Merck, Daiichi Sankyo retract accelerated approval request for lung cancer ADC
Merck, Daiichi Sankyo retract accelerated approval request for lung cancer ADC
Publication of ROADS Phase 3 Clinical Trial Data in Journal of Clinical Oncology Recommends GammaTile® as a New Standard-of-Care Option for Newly Diagnosed Operable Brain Metastases1
Publication of ROADS Phase 3 Clinical Trial Data in Journal of Clinical Oncology Recommends GammaTile® as a New Standard-of-Care Option for Newly Diagnosed Operable Brain Metastases1
US details rules for pharmaceutical tariff exemptions
US details rules for pharmaceutical tariff exemptions
UTR Therapeutics Inc. Announces U.S. FDA Orphan Drug Designation and Rare Pediatric Disease Designation for UTRxMYCN M1-14
UTR Therapeutics Inc. Announces U.S. FDA Orphan Drug Designation and Rare Pediatric Disease Designation for UTRxMYCN M1-14
6 immunology targets to sustain a mammoth I&I market
6 immunology targets to sustain a mammoth I&I market
AI is eroding the barriers that kept biological weapons rare
AI is eroding the barriers that kept biological weapons rare
BioNTech to close sites in Germany after failed sale
BioNTech to close sites in Germany after failed sale
Lilly to expand global GLP-1 access by 2040
Eli Lilly's weight loss and diabetes medicines have become a dominant force in the market, but access varies widely around the world. A new initiative aims to take GLP-1s to lower-income nations by 2040.
Lupin Receives Tentative Approval from U.S. FDA for Novel Apixaban Oral Suspension
Lupin has received tentative approval from the U.S. FDA for Apixaban Oral Suspension 1.25 mg/mL, an oral liquid formulation of the active ingredient in Eliquis that offers an alternative administration option for adults requiring anticoagulation therapy.
Merck inks up to $2.13B deal to dine with SciBrunch, gain rights to preclinical KRAS inhibitor
Merck continues to diversify its cancer efforts as the clock ticks down on Keytruda's patent, picking up rights to a preclinical oncology asset in a deal that could exceed $2 billion.
MSD, Daiichi pull filing for lung cancer candidate I-DXd
MSD and Daiichi Sankyo's regulatory efforts for their ADCs for cancer have stuttered again, with a withdrawn filing for lung cancer candidate I-DXd.
Roche culls myostatin candidate from obesity pipeline
Roche has abandoned the development of one of its obesity candidates, emugrobart, and returned rights to originator Chugai Pharma.
Test could end uncertainty in inherited muscle diseases
A new study suggests long-read 'nanopore' sequencing could transform the diagnosis of inherited diseases and unlock new insights for drug discovery.
U.S. FDA Approves AbbVie's JUVMO™ (tavapadon) for Parkinson's Disease
AbbVie's JUVMO (tavapadon) is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson's disease. The once-daily tablet works with or without levodopa, and the approval is supported by the Phase 3 TEMPO programme.
Australia starts probe into AI infiltration of Medicare
The infiltration of Australia's Medicare by an AI agent raises serious questions about patient privacy and the security of confidential pharma data.
ADARx raises $446M in biotech's third largest IPO of 2026, City files to go public
Two RNA biotechs, ADARx Pharmaceuticals and City Therapeutics, are taking advantage of an IPO window that has produced 27 newly public biotechs so far this year, with ADARx raising $446 million.
After COVID, biomanufacturing tackles preparedness and commercialization challenges
Manufacturers are redesigning their processes to balance both better future emergency vaccine mobilization and the more demanding work of maintaining flexible, commercially viable manufacturing networks.
EU clears first drug therapy for rare disease cALD
Neuraxpharm and Minoryx' Nezglyal has become the first approved drug therapy in the EU for rare neurodegenerative disease cALD.
J&J, Legend tout long-term survival benefits for Carvykti in multiple myeloma
Ten patients out of 20 who received Johnson & Johnson and Legend Biotech’s Carvykti remained alive at five years of follow up.
Merck, Eisai's Welireg-Lenvima combo lands FDA nod to jump the kidney cancer queue
The FDA approved Merck's HIF-2 alpha inhibitor Welireg in combination with Eisai-partnered Lenvima for second-line clear cell renal cell carcinoma following a PD-(L)1 inhibitor, lifting the drug beyond its original third-line use.
Mylan asks US court to clear Wegovy generic from Novo patent claims
Mylan asks US court to clear Wegovy generic from Novo patent claims
Nektar prevails in legal battle with Lilly over broken rezpeg partnership
A jury awarded Nektar Therapeutics $90 million in damages after siding with the biotech, which accused Eli Lilly of botching an analysis of their formerly partnered autoimmune drug.
Acadia misses mark in Alzheimer's but continues phase 3 program
Acadia Pharmaceuticals' drug missed the mark in a mid-stage Alzheimer's psychosis study, but the company said it saw enough signal to continue with a modified Phase 3 program.
Biogen springs kidney health campaign with gymnast Suni Lee
Biogen is launching a kidney health campaign featuring Olympic gymnast Suni Lee.
Boehringer Ingelheim offloads Shanghai CDMO to local antibody developer
Boehringer Ingelheim is selling its biologics contract manufacturing unit in China to Shanghai-based Raas Blood Products for up to 20 million Chinese yuan (around $3 million), giving the local developer a 6,000-liter commercial production facility.
Genentech makes $1.5B+ deal with AI heavyweight Earendil for cancer bispecifics
Genentech is paying $55 million upfront to work with AI biotech Earendil Labs to discover and develop several bispecific antibody cancer therapies, in a heavily backloaded deal that could top $1.5 billion.
Glaukos taps Stephen Curry for keratoconus awareness campaign
Glaukos is teaming up with NBA champion Stephen Curry on a campaign to raise awareness of keratoconus.
Lakewood-Amedex Biotherapeutics Announces First Patient Dosed in Phase 2a Clinical Trial of NU-3 for Infected Diabetic Foot Ulcers
Lakewood-Amedex Biotherapeutics said the first patient has been dosed in a Phase 2a trial of NU-3 for infected diabetic foot ulcers.
Peer-Reviewed Study Published in Spine Open Demonstrates Superior Two-Year Clinical Outcomes for FDA-Approved Synergy Disc® Compared with Cervical Fusion
The prospective U.S. IDE study found higher clinical success, reduced neck and arm pain and greater patient satisfaction with the Synergy Disc compared with anterior cervical discectomy and fusion at 24 months.
The human cost of AI interviews
While artificial intelligence can help biotech and pharma companies more quickly vet job applicants, it can also turn off the very people they want to employ. Two recruiting experts discuss AI’s role and limitations in the hiring process.
AI drug hunter Enveda raises $311M for late-stage obesity, inflammatory disease push
Enveda, which is working on an “exercise in a tablet” oral obesity candidate, has collected $311 million in a Series E crossover round to support the advancement of three medicines into late-stage development.
Basecamp raises $140M Series C, unveils six-program pipeline in test of its AI
Basecamp Research has raised a $140 million Series C, valuing the AI drug discovery company near $1 billion, as CEO Glen Gowers outlined a six-program pipeline guided by its EDEN model.
Celldex falls on safety concern, even as chronic hives drug succeeds in Phase 3 trials
Celldex said its experimental treatment barzolvolimab hit its primary endpoint in two Phase 3 trials, even as the readout raised safety concerns.
China’s surging biotech sector represents both competition and lifeline for the US
As Chinese companies push beyond “me-too” drugs and the country lays out a new five-year plan targeting a $522 billion–strong biotech industry by 2030, experts say more predictable funding and regulation could help the U.S. maintain its edge.
FDA Advisory Committee Votes In Favor of Approval of GRAIL's Galleri Multi-Cancer Early Detection Test
An FDA advisory committee voted in favor of approving GRAIL's Galleri multi-cancer early detection test.
Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions
A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.
GSK aiming to ‘balance West and East’ since Hansoh deal success
GSK has been operating a strategy of “balancing the West and the East” since the British pharma’s eyes were opened to the potential of licensing drugs from China a few years ago, according to an executive.
Roche inks up to $2B deal with Atavistik for new cardiometabolic drugs
Roche has signed a deal worth up to $2 billion with Atavistik Bio to discover new cardiometabolic drugs.
Roivant reports Phase 2b lupus failure for an FcRn drug
One of Roivant's leading autoimmune pipeline candidates failed a Phase 2b study in a form of lupus, the company said Wednesday morning.
Viking touts once-a-month maintenance data for its weight loss candidate
Viking Therapeutics says patients who switched to a once-a-month dosing regimen of its obesity drug did not regain much weight after 12 weeks.
AIMD Expands A-LRYNGO, the World's First AI-Guided Video Laryngoscope, to Global Markets
AIMD Inc., a Korean medical technology company specializing in AI-powered emergency care, announced the global expansion of A-LRYNGO™, the...
Amgen fusion protein eases Sjögren's severity in ph. 3 win
An investigational drug for the autoimmune condition Sjogren's disease has scored a phase 3 win for Amgen, marking a positive sign for the Horizon Therapeutics-acquired pipeline that has so far struggled to gain traction.
Boehringer Ingelheim bets up to $1B in AI-centered solid tumor collab with Envisagenics
Envisagenics’ platform makes use of AI to screen and detect cancer-specific RNA alterations, which Boehringer Ingelheim wants to target through various precision treatment modalities, including multi-specific antibodies, antibody-drug conjugates and T cell engagers.
FDA Grants Orphan Drug Designation to Kedrion's QIVIGY® for Stiff Person Syndrome, an Ultra-Rare Neurological Disorder
Kedrion Biopharma announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Immune globulin...
KVK-Tech Completes FDA REMS Inspection with No Observations
KVK-Tech said it completed an FDA REMS inspection with no observations.
Lexeo acquires Mantle for $8M, adding Friedreich ataxia assets
Lexeo Therapeutics has agreed to acquire Mantle Therapeutics via an upfront payment of $8.3 million, aiming to expand its Friedreich’s ataxia (FA) portfolio while locking in three strategic collabo | Lexeo Therapeutics has agreed to acquire Mantle Therapeutics via an upfront payment of $8.…
Nvidia-backed Iambic files for IPO, disclosing new clinic and dealmaking details
Iambic Therapeutics has filed to go public and says it could move IAM1363, its lead drug targeting HER2 cancers, into a registrational trial as early as next year.
Western licensing deals for Chinese radioligand therapies to jump in 2027, Sleuth forecasts
Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
Citing Replimune approval, experts say localized cancer meds could redefine care
Delivering therapeutics directly to tumors, as with Replimune's recently approved Tudriqev and Amgen's Imlygic, holds advantages especially when cancer is caught early, but challenges remain before the approach becomes a mainstay in treatment.
Cue chalks up phase 2 hives win for Xolair challenger
A midstage study of Cue Biopharma's CUE-221 hit its primary endpoint in chronic spontaneous urticaria, emboldening the biotech to move the would-be Xolair challenger into a phase 2b/3 trial.
Iambic releases next version of its Enchant model, signs deal with AbbVie
Iambic launched Enchant v3, a 41-billion-parameter AI model, and signed an R&D deal with AbbVie covering small molecules in immunology, neuroscience and oncology.
Mikhail, Davis on board with regulatory framework tailored to rare disease therapies
Newly permanent CBER and CDER directors Karim Mikhail and Michael Davis are widely expected to continue the FDA's push toward an adaptive regulatory framework for rare disease therapies, pending Senate confirmation.
Novo aims to diversify with new pipeline assets and bolt-on deals
At its capital markets day Novo unveiled pipeline-diversification and bolt-on deal plans, but shares slid 5% as investors wanted bigger swings.
QinFlow Launches PressSure, a New Device to Simplify Infusion Pressure Management Across Critical Care
QinFlow launched PressSure, a compact, lightweight, battery-powered device that maintains pressure during blood and IV fluid delivery, replacing the manual inflate-monitor-reinflate routine of standard pressure bags.
Artelo cannabinoid agonist holds its own against semaglutide
Artelo Biosciences' cannabinoid agonist held its own against GLP-1 drugs in obese mice, per a preclinical study.
China plans to transform biotech sector into $522B powerhouse by 2030
China has laid out plans to grow its biotech sector into a $522 billion powerhouse by 2030.
Doctors should educate patients about ‘Asian glow’ and drinking risks
An explainer on 'Asian glow' - the alcohol-flushing response linked to the ALDH2 variant - and why clinicians should counsel patients on drinking risks.
Electra lights up with $350M IPO for pivotal immune-disease drug development
Electra Therapeutics raised $350M in an upsized IPO to fund pivotal development of its immune-disease drug.
After failed acquisition, Lisata finds lifeline in Marea merger
After failed acquisition, Lisata finds lifeline in Marea merger
North Immunology joins biotech reverse merger boom with Aethlon deal
North Immunology is going public through an all-stock reverse merger with Aethlon Medical, paired with an oversubscribed $180 million private placement that is expected to fund its eczema drug program into the second half of 2028.
RIVANNA announces new CMS procedure code for computer-aided neuraxial guidance
RIVANNA has secured a new CMS procedure code covering computer-aided neuraxial guidance.
5 biotechs braving the commercial waters with product launches
A growing number of biotechs are entering the market with newly launched medicines, a pattern indicative of “improving capital markets,” according to Jefferies’ Andrew Tsai.
AI is changing the talent biotech companies compete to hire
As AI becomes more embedded in biotech R&D, companies are competing for professionals who can bridge biology, machine learning, data and engineering. Recruiting expert Darren Nelson explains which capabilities are becoming hardest to find—and why.
AZ, Daiichi's Enhertu nabs long-sought NHS blessing from NICE
AZ, Daiichi's Enhertu nabs long-sought NHS blessing from NICE
Centric Compounding recalls three injectables over contamination
Centric Compounding recalls six lots of Glutathione, Myers' Cocktail and Tri-Immune Boost injections over endotoxin contamination after nine adverse event reports.
Could UK clinical trial revamp unlock closer ties with Canada?
Two senior figures in Canada's life science sector have said they see scope for greater collaboration with the UK following clinical trial reforms.
DifGen Pharmaceuticals LLC Announces U.S. FDA Approval of Epinephrine Injection USP, 1 mg/mL, Single-Dose Vials
DifGen Pharmaceuticals LLC Announces U.S. FDA Approval of Epinephrine Injection USP, 1 mg/mL, Single-Dose Vials
KELLS AI Dental Scan Registered as Class B Medical Device with Singapore HSA
KELLS said its AI Dental Scan became Singapore's first HSA-registered AI dental screening tool designed for direct consumer use, after registration as a Class B medical device.
Novartis pays Sironax $125M to acquire brain delivery platform
News from Fierce Biotech: Novartis pays Sironax $125M to acquire brain delivery platform
Novartis' TREM2 drug fails Phase 2 ALS trial
The Swiss pharma giant is ending work on VHB937/lifonebart in ALS, according to a letter from the company's clinical development team.
Novo, Anthropic sign deal to apply AI to drug discovery
Anthropic partners with Novo to tackle drug discovery using Claude Science AI. Financial terms undisclosed. Novo also has a similar deal with OpenAI.
Sionna cuts nearly half of staff as it lines up second attempt at cystic fibrosis
Sionna Therapeutics announced it was laying off 46% of its staff as it seeks a way forward following an unexpected trial failure in cystic fibrosis last month.
SMSbiotech Receives FDA "Study May Proceed" Notification for First U.S. IND-Cleared Inhaled Stem Cell Therapy in COPD
SMSbiotech said the FDA allowed its IND to proceed for inhaled allogeneic SMS Cells in COPD, the first U.S. IND-cleared inhaled stem cell therapy for the disease, with a Phase 1b trial targeted to begin in Q4 2026.
UK review recommends 'L plates' for new healthcare AIs
A report has concluded that the current regulatory framework in the UK is inadequate for healthcare AI, and makes 44 recommendations to set it right.
Applied Photonix Launches ViroZap, the First FDA-Cleared Medical Device for In-Duct Air Disinfection
News from PR Newswire: Applied Photonix Launches ViroZap, the First FDA-Cleared Medical Device for In-Duct Air Disinfection
AstraZeneca's newly approved pill fails frontline breast cancer study
News from BioPharma Dive: AstraZeneca's newly approved pill fails frontline breast cancer study
Axoltis says its Phase 2 study for an experimental ALS drug failed
News from Endpoints News: Axoltis says its Phase 2 study for an experimental ALS drug failed
Connect not dismayed by Dupixent rival's ph. 2 asthma failure
News from Fierce Biotech: Connect not dismayed by Dupixent rival's ph. 2 asthma failure
Contineum, J&J's drug fails in mid-stage depression trial
News from Endpoints News: Contineum, J&J's drug fails in mid-stage depression trial
Despite 3 patient deaths, Cullinan-Taiho plan FDA filing for lung cancer pill on survival benefit
News from BioSpace: Despite 3 patient deaths, Cullinan-Taiho plan FDA filing for lung cancer pill on survival benefit
Electra sets terms for IPO, hoping to raise up to $347m
News from Pharmaphorum: Electra sets terms for IPO, hoping to raise up to $347m
Exclusive: Kairon Health raises $5M to use data to make patients healthier
News from Endpoints News: Exclusive: Kairon Health raises $5M to use data to make patients healthier
AAM sounds alarm on unsustainable race to the bottom for generics and biosimilars
News from BioSpace: AAM sounds alarm on unsustainable race to the bottom for generics and biosimilars
Acurx Announces Presentation of a Scientific Poster at the International C. difficile Symposium on Ibezapolstat Kill Kinetics
Acurx said a scientific poster at the International C. difficile Symposium showed superior in vitro kill kinetics for ibezapolstat versus vancomycin and fidaxomicin in C. difficile and vancomycin-resistant Enterococcus co-cultures.
AstraZeneca newly approved cancer pill fails late-stage study in untreated advanced breast cancer
AstraZeneca next-generation SERD has disappointed in a Phase 3 trial for untreated advanced breast cancer.
AstraZeneca's newly approved cancer pill fails late-stage study, blocking path to bigger market
News from BioSpace: AstraZeneca's newly approved cancer pill fails late-stage study, blocking path to bigger market
Cyclic peptides open new drug frontiers, if manufacturing can keep up
With oral cyclic peptides offering small molecule convenience and antibody‑like selectivity, the modality is gaining momentum. But bioavailability below 1%, minimal PK data and fragile synthesis still
Akeso details survival win for its PD-1xVEGF drug versus Keytruda
Akeso reports strong overall survival data for its PD-1xVEGF bispecific antibody ivonescimab, demonstrating superiority over Keytruda in PD-L1-high NSCLC.
AstraZeneca’s Etcamah flunks first-line breast cancer trial
AstraZeneca's oral SERD Etcamah fails to meet primary endpoint in first-line breast cancer trial, adding to the company's setbacks in this drug class.
Failed Trodelvy first-line NSCLC trial shows better China data
Merck and Gilead's Trodelvy shows improved results in Chinese patients with first-line NSCLC, despite the global trial failing to meet its primary endpoint.
Yarrow brings in more cash; AbbVie drug succeeds in menstrual migraine trial
Yarrow Bioscience secures additional funding; AbbVie's Qulipta succeeds in menstrual migraine trial, expanding its potential market.
ai3Bio, built from two biotechs, pursues a different path to an 'immune reset'
Rather than deplete malfunctioning B cells as many other emerging autoimmune drugs do, Ai3Bio’s therapies are designed to eliminate a particular group of T helper cells.
Alzheon outlines plans for major fundraising round despite Phase 3 miss for Alzheimer's drug
Alzheon outlines plans for major fundraising round despite Phase 3 miss for Alzheimer's drug — latest biopharma news.
AstraZeneca invests $2B in Summit, gaining 'seat at the table' for PD-1/VEGF drug push
The equity investment comes alongside a deal to test Summit’s ivonescimab alongside potentially many AstraZeneca drugs — but doesn’t hand the pharmaceutical company any ownership rights.
Disc sets up polycythemia vera challenge but Silence maintains lead
Disc Medicine presents a competitive challenge in polycythemia vera, but Silence Therapeutics maintains its lead in the space.
Medicaid will let states use ‘tiers’ to determine medical frailty
Medicaid will allow states to use a tiered system to determine medical frailty, affecting work requirement exemptions for beneficiaries.
Mikhail, Davis embody the FDA’s stabilization, Seehafer signals AI revolution is coming
Mikhail, Davis embody the FDA’s stabilization, Seehafer signals AI revolution is coming — latest biotech and pharma news.
Takeda, Daiichi, Samsung Bio and more—Fierce Pharma Asia
Takeda, Daiichi, Samsung Bio and more—Fierce Pharma Asia — latest pharmaceutical industry news.
U.S. officials declare an end to record-setting cyclospora outbreak, but its origin is still unknown
U.S. health officials declare an end to a record-setting cyclospora outbreak, though the origin of the parasitic infection remains unknown.
AbbVie eyes Qulipta expansion after menstrual migraine win
AbbVie eyes Qulipta expansion after menstrual migraine win
AbbVie eyes Qulipta expansion after menstrual migraine win
AbbVie eyes Qulipta expansion after menstrual migraine win — latest pharmaceutical industry news.
Biohaven takes another hit as FDA pauses enrollment in pivotal trials for embattled epilepsy drug
Biohaven takes another hit as FDA pauses enrollment in pivotal trials for embattled epilepsy drug
Consano Bio Announces Peer-Reviewed Publication Supporting the Therapeutic Potential of C-1101 in Chronic, Painful Lumbosacral Radiculopathy (LSR) or Chronic Sciatica
Consano Bio Announces Peer-Reviewed Publication Supporting the Therapeutic Potential of C-1101 in Chronic, Painful Lumbosacral Radiculopathy (LSR) or Chronic Sciatica — latest FDA regulatory news.
Encoded raises $275M series F for Dravet syndrome gene therapy
Encoded raises $275M series F for Dravet syndrome gene therapy
Fluence Selected by Compass Pathways to Develop Post-Approval COMP360 Provider Training
Fluence Selected by Compass Pathways to Develop Post-Approval COMP360 Provider Training — latest FDA regulatory news.
Seismic Pharmaceuticals Announces the Enrollment of the First Patient in the Global Phase 3 Trial of Istaroxime in Cardiogenic Shock
Seismic Pharmaceuticals Announces the Enrollment of the First Patient in the Global Phase 3 Trial of Istaroxime in Cardiogenic Shock — latest FDA regulatory news.
Shionogi's stroke drug fails mid-stage; Bayer's Hyrnuo gets expanded label in NSCLC
Shionogi's stroke drug fails mid-stage; Bayer's Hyrnuo gets expanded label in NSCLC
The blueprint for clinical AI
The blueprint for clinical AI
The supply chain fault lines of modern pharma
The supply chain fault lines of modern pharma
Trump officials say AI will help save rural health care. Some leaders in the field don't believe it
Trump officials say AI will help save rural health care. Some leaders in the field don't believe it
A new immuno-oncology play raises $225M for a next-generation drug
News from BioPharma Dive: A new immuno-oncology play raises $225M for a next-generation drug
AMA CEO: AI won’t replace doctors — it will work alongside them
News from STAT News: AMA CEO: AI won’t replace doctors — it will work alongside them
ARPA-H selects companies to build AI tools for heart disease
News from Endpoints News: ARPA-H selects companies to build AI tools for heart disease
ARPA-H Selects UpDoc to Lead Development of Autonomous Clinical AI System, in an Initiative Joined by Microsoft, OpenAI and NVIDIA
ARPA-H Selects UpDoc to Lead Development of Autonomous Clinical AI System, in an Initiative Joined by Microsoft, OpenAI and NVIDIA
Autonomous AI will beat AI-assisted physicians at some medical tasks by 2030
News from STAT News: Autonomous AI will beat AI-assisted physicians at some medical tasks by 2030
Coroner releases details of infants who died amid growing Pennsylvania measles outbreak
Coroner releases details of infants who died amid growing Pennsylvania measles outbreak
Evommune gives up on dermatitis drug after another ph. 2 fail
News from Fierce Biotech: Evommune gives up on dermatitis drug after another ph. 2 fail
FDA gains continuity as Mikhail, Davis named permanent CBER, CDER leaders
News from BioPharma Dive: FDA gains continuity as Mikhail, Davis named permanent CBER, CDER leaders
Novo’s canned heart disease trials, Novartis’ clinical fails, first approval for Alexander disease
News from BioSpace: Novo’s canned heart disease trials, Novartis’ clinical fails, first approval for Alexander disease
nPhase launches AI data platform to improve sponsor trial design
nPhase launches AI data platform to improve sponsor trial design
Sandoz plans ‘vast and vertically integrated’ supply chain to support 100-biosimilar vision
Sandoz plans ‘vast and vertically integrated’ supply chain to support 100-biosimilar vision
BrainChild Bio targets deadly pediatric brain cancer with $116M series A
BrainChild Bio targets deadly pediatric brain cancer with $116M series A
Brainomix and Endeavor BioMedicines Present Positive Results from Quantitative Image Analysis of Phase 2a Idiopathic Pulmonary Fibrosis (IPF) Trial at ERS Congress
Brainomix and Endeavor BioMedicines Present Positive Results from Quantitative Image Analysis of Phase 2a Idiopathic Pulmonary Fibrosis (IPF) Trial at ERS Congress
Hospitals pursue deals to ensure survival as Trump’s Medicaid cuts loom
Hospitals pursue deals to ensure survival as Trump’s Medicaid cuts loom
Moonwalk pulls in $70M to take fat-targeting RNAi obesity candidate to clinic
Moonwalk pulls in $70M to take fat-targeting RNAi obesity candidate to clinic
Novartis’ cholesterol-lowering medicine fails Phase 3, clouding Lp(a) horizons
Novartis’ cholesterol-lowering medicine fails Phase 3, clouding Lp(a) horizons
Reeling from past failures, Parkinson’s pipeline enters ‘era of diversification’
Reeling from past failures, Parkinson’s pipeline enters ‘era of diversification’
Roche sweeps neurology corporate reputation rankings once again
Roche sweeps neurology corporate reputation rankings once again
BrainChild Bio gets $116M for pivotal trial of pediatric brain tumor CAR-T
News from Endpoints News: BrainChild Bio gets $116M for pivotal trial of pediatric brain tumor CAR-T
CART Blood Pressure Monitor Demonstrates Utility in BP Monitoring for AF and Heart Failure Patients
A new blood pressure monitor from CART demonstrates clinical utility for monitoring patients with atrial fibrillation and heart failure.
Moonwalk raises $70M to test siRNA treatment for obesity
News from Endpoints News: Moonwalk raises $70M to test siRNA treatment for obesity
Novartis' Phase 3 cardiovascular study miss raises the stakes for Amgen, Lilly
Novartis' Phase 3 pelacarsen study miss in cardiovascular disease raises competitive stakes for Amgen and Eli Lilly in the space.
AZ goes full AI-animal in new Breztri ad
AstraZeneca launches a new AI-generated ad campaign featuring a llama to promote its Breztri combination inhaler for COPD.
What STAT readers think about M.D. vs. D.O., AI in medicine, surrogacy, and more
What STAT readers think about M.D. vs. D.O., AI in medicine, surrogacy, and more
AbbVie-allied ADARx aims to go public with 3 drugs in the clinic
ADARx Pharmaceuticals, allied with AbbVie, files for an IPO with three RNA-based therapeutics advancing through clinical trials.
Daiichi unit recalls 3 epinephrine lots after complaints in US
Daiichi unit recalls 3 epinephrine lots after complaints in US
FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
Former I-Mab chief Joan Shen's NeuShen banks $80M+ for 3 brain-health drugs
NeuShen Therapeutics, founded by former I-Mab CEO Joan Shen, raises over $80 million to develop three brain-health drug candidates.
Invivyd's chair adds CEO role ahead of readout—Chutes & Ladders
Article from Fierce Biotech about Invivyd's chair adds CEO role ahead of readout—Chutes & Ladders.
Morning Rounds
STAT News daily newsletter covering health policy, disability insurance risks, and the latest in medical research.
Novartis Lp(a) drug fails closely watched ph. 3 trial
Novartis Lp(a) drug fails closely watched ph. 3 trial
The FDA removed the red tape around one of the best drugs for children with schizophrenia. But the fear remains
Article from STAT News about The FDA removed the red tape around one of the best drugs for children with schizophrenia. But the f.
CBER official overruled review team's rejection of new Replimune melanoma drug
A CBER official overruled the review team's rejection of Replimune's new melanoma drug, raising questions about FDA decision-making.
Deaths in Novartis CAR-T trial force a reckoning over acceptable risk in autoimmune disease
Patient deaths in a Novartis CAR-T cell therapy trial raise fundamental questions about acceptable risk in autoimmune disease treatment.
Novartis teams with Olympian Laviai Nielsen on MS campaign
Article from Fierce Pharma about Novartis teams with Olympian Laviai Nielsen on MS campaign.
Psilocybin proves promising in neuropathic pain mouse study
Article from Fierce Biotech about Psilocybin proves promising in neuropathic pain mouse study.
Replimune’s melanoma drug would have been rejected again if not for senior CBER official
Replimune’s melanoma drug would have been rejected again if not for senior CBER official
Summit, Akeso’s ivonescimab bests Merck’s Keytruda in China trial—again
Summit, Akeso’s ivonescimab bests Merck’s Keytruda in China trial—again
Superluminal secures $60M for Phase 1 of genetic obesity drug
Superluminal Medicines raises $60 million to advance its genetic obesity drug candidate into Phase1clinical trials.
Ultragenyx fails ph. 3 Angelman test as shares tumble
Ultragenyx fails ph. 3 Angelman test as shares tumble
Ultragenyx’s ‘high-risk’ Angelman bet fails, cratering stock and forcing strategic review
Ultragenyx’s ‘high-risk’ Angelman bet fails, cratering stock and forcing strategic review
ARPA-H taps 5 teams to help streamline RNA therapy production
ARPA-H taps 5 teams to help streamline RNA therapy production
Bayesian Health's FDA-Cleared Continuous AI Sepsis Monitor Approved for Medicare New Technology Add-on Payment (NTAP)
Bayesian Health's FDA-Cleared Continuous AI Sepsis Monitor Approved for Medicare New Technology Add-on Payment (NTAP)
FDA Allows First Gene Therapy Clinical Trial for Ultra-Rare Pediatric Neurodegenerative Disease
FDA Allows First Gene Therapy Clinical Trial for Ultra-Rare Pediatric Neurodegenerative Disease
FDA raises bar for foreign site inspections as China trials surge
FDA raises bar for foreign site inspections as China trials surge
Stripped of AstraZeneca safety net, BMS could face ‘carnage’ if high-risk clinical trial fails
Stripped of AstraZeneca safety net, BMS could face ‘carnage’ if high-risk clinical trial fails
Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing
Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing
9 midsize drugmakers climb aboard Trump’s MFN train
9 midsize drugmakers climb aboard Trump’s MFN train. Published by BioSpace on 2026-09-01.
Alumis falls after TYK2 pill fails lupus study, but CEO sees 'clear path forward'
Alumis falls after TYK2 pill fails lupus study, but CEO sees 'clear path forward'. Published by Endpoints News on 2026-09-01.
ARCH Venture Partners targets $3 billion raise for latest fund
ARCH Venture Partners targets $3 billion raise for latest fund. Published by Endpoints News on 2026-09-01.
GSK's Pivotal Test for mRNA Flu Vaccine Aims to Show Two Targets Are Better Than One
GSK's Pivotal Test for mRNA Flu Vaccine Aims to Show Two Targets Are Better Than One
North Carolina Approves Reimbursement of VR Therapy for Neurodivergent Residents Under NC Innovations Waiver
North Carolina Approves Reimbursement of VR Therapy for Neurodivergent Residents Under NC Innovations Waiver. Published by PR Newswire FDA on 2026-09-01.
Novartis Gains a Way to Get Drugs Into the Brain, Buying Sironax Tech for $125M
Novartis Gains a Way to Get Drugs Into the Brain, Buying Sironax Tech for $125M
Ultragenyx Trial Failure Revives Debate About How to Treat a Rare Neuro Disorder
Article from MedCity News about Ultragenyx Trial Failure Revives Debate About How to Treat a Rare Neuro Disorder.
Amai Proteins' sweelin® Approved for Sale in Israel, Opening the Market to a New Generation of Reduced-Sugar Food and Beverage Products
Amai Proteins' sweelin® Approved for Sale in Israel, Opening the Market to a New Generation of Reduced-Sugar Food and Beverage Products
Arrowhead claims safety edge over Ionis as triglyceride battle draws closer
Arrowhead claims safety edge over Ionis as triglyceride battle draws closer
AstraZeneca's heart failure drug shows promise in ph. 2 trial
AstraZeneca's heart failure drug shows promise in ph. 2 trial. Published by Fierce Biotech on 2026-08-31.
AstraZeneca's relaxin pill shows promise in mid-stage heart failure trial
AstraZeneca's relaxin pill shows promise in mid-stage heart failure trial
BMS’ neuro renaissance was built on back of Celgene mega-merger
BMS’ neuro renaissance was built on back of Celgene mega-merger
Electra aims to light up Nasdaq with IPO for phase 2/3 I&I push
Electra aims to light up Nasdaq with IPO for phase 2/3 I&I push. Published by Fierce Biotech on 2026-08-31.
Emergent spreads overdose awareness campaign across US, Canada
Emergent spreads overdose awareness campaign across US, Canada. Published by Fierce Pharma on 2026-08-31.
FDA dings Alar over ‘extremely concerning’ ketamine claims
FDA dings Alar over ‘extremely concerning’ ketamine claims. Published by Fierce Pharma on 2026-08-31.
New guidelines on migraine prevention reflect increasing options for patients
New guidelines on migraine prevention reflect increasing options for patients. Published by STAT News on 2026-08-31.
Ultra Violette Becomes First Brand in the US to Launch a Sunscreen Containing Newly FDA-Approved Filter Bemotrizinol
Ultra Violette Becomes First Brand in the US to Launch a Sunscreen Containing Newly FDA-Approved Filter Bemotrizinol. Published by PR Newswire FDA on 2026-08-31.
Novartis pushes ahead with its IL-6 inhibitor despite Novo's failure
Novartis pushes ahead with its IL-6 inhibitor despite Novo's failure
At a federal autism advisory committee meeting, members double down on long-debunked theories
Federal autism advisory committee members reiterate discredited theories about autism causation, raising concerns among scientists and patient advocates.
Biogen platforms lupus patient advocate in social media push
Biogen enlists lupus patient advocates for a social media campaign to raise awareness and drive engagement around its lupus franchise.
Daiichi Sankyo to give commercial team a makeover; Novo Nordisk's GPCR partner finds CMO
Daiichi Sankyo to give commercial team a makeover; Novo Nordisk's GPCR partner finds CMO
Future of AstraZeneca’s gene silencer in heart disease uncertain after trial failure
Future of AstraZeneca’s gene silencer in heart disease uncertain after trial failure
Success after a century of failures: Inside Moderna and Merck's cancer vaccine breakthrough
Success after a century of failures: Inside Moderna and Merck's cancer vaccine breakthrough
We quit the CDC last year. The problems we protested remain
We quit the CDC last year. The problems we protested remain
‘Worse than expected’ Wainua data muddies water for TTR silencers
Disappointing clinical data from Alnylam's Wainua raises questions about the broader TTR silencer class and competitive positioning.
Anthropic AI tool conducts physical scientific experiments
Anthropic AI tool conducts physical scientific experiments
Hospitals are plotting a long-shot push to roll back $1 trillion in Medicaid cuts
Hospitals are plotting a long-shot push to roll back $1 trillion in Medicaid cuts
RFK Jr. said a Samoa trip had nothing to do with vaccines. New documents refute that
RFK Jr. said a Samoa trip had nothing to do with vaccines. New documents refute that. Published by STAT News on 2026-08-27.
Summit, Akeso tout biliary cancer win for PD-1/VEGF in China—but details are pending
Summit, Akeso tout biliary cancer win for PD-1/VEGF in China—but details are pending
With mRNA back in the spotlight, tRNA shows potential
Transfer RNA (tRNA) therapeutics emerge as a promising modality as the broader RNA therapeutics field gains momentum beyond mRNA vaccines.
An uncertain future for Aurora, the first startup dedicated to custom CRISPR therapies
An uncertain future for Aurora, the first startup dedicated to custom CRISPR therapies
Exclusive: Can AI chop clinical trial timelines in half? Faro raises $37M to find out
Exclusive: Can AI chop clinical trial timelines in half? Faro raises $37M to find out
Amplio Spine™ Appoints Nomen Azeem, MD, as Chief Clinical Officer and Founding Chair of the Clinical Advisory Board
Amplio Spine™ Appoints Nomen Azeem, MD, as Chief Clinical Officer and Founding Chair of the Clinical Advisory Board
ARCH and Population Health join China blitz with Haisco deal
ARCH Venture Partners and Population Health Partners are joining the China biotech investment wave through a new deal with Haisco.
Bausch + Lomb advances dry eye disease drug to Phase 3 despite mid-stage fail
Bausch + Lomb advances dry eye disease drug to Phase 3 despite mid-stage fail
Cambrex High Point achève les inspections préalables à l'autorisation menées par la FDA, la PMDA et la TGA, renforçant ainsi ses capacités de production commerciale
Cambrex High Point achève les inspections préalables à l'autorisation menées par la FDA, la PMDA et la TGA, renforçant ainsi ses capacités de production commerciale
China’s Haisco forms immunology biotech with up to $1.5B from American VCs
China’s Haisco forms immunology biotech with up to $1.5B from American VCs
EyePoint plummets on pivotal data for main drug
EyePoint plummets on pivotal data for main drug
FDA extends review of Capricor cell therapy; Pain drug startup to go public
FDA extends review of Capricor cell therapy; Pain drug startup to go public
Lundbeck partners with Eversana to broaden AI scope
Lundbeck partners with Eversana to broaden AI scope
NAD reaches split decision on Kenvue-Hims & Hers hair ad row
NAD reaches split decision on Kenvue-Hims & Hers hair ad row
Regenxbio hit with another clinical hold for Hunter syndrome gene therapy
Regenxbio has been hit with another clinical hold for its Hunter syndrome gene therapy program, raising safety concerns.
Safety concerns spur FDA to again halt testing of Regenxbio gene therapy
Safety concerns spur FDA to again halt testing of Regenxbio gene therapy
Sentante takes physical AI to market, beginning commercial rollout in vascular surgery and interventional radiology
Sentante takes physical AI to market, beginning commercial rollout in vascular surgery and interventional radiology
Avulux Granted FDA De Novo Authorization, Creating the First Lens Classification for Migraine-Associated Light Sensitivity
Avulux Granted FDA De Novo Authorization, Creating the First Lens Classification for Migraine-Associated Light Sensitivity
Daiichi promotes Ken Keller to lead new commercialization unit
Daiichi promotes Ken Keller to lead new commercialization unit
FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients
FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients
Medicine stopped shaking hands. We should start again
Medicine stopped shaking hands. We should start again
Nurse practitioner trainees find themselves stymied by shortage of clinical mentors
A shortage of clinical mentors is creating bottlenecks for nurse practitioner trainees across the U.S. healthcare system.
Option-to-acquire deals remain rare in biotech's buzzy M&A season
Option-to-acquire deals remain rare in biotech's buzzy M&A season
TME's hunt for partner for brain cancer nears conclusion
TME's hunt for partner for brain cancer nears conclusion
AI, genomics expert leaves Pathos AI, will advise Pfizer
AI, genomics expert leaves Pathos AI, will advise Pfizer
AI in Pharmacovigilance: Why Governance Will Define Success
AI in Pharmacovigilance: Why Governance Will Define Success
Ambros Therapeutics’ Path for Pain Drug Goes Through Reverse Merger With Werewolf
Ambros Therapeutics’ Path for Pain Drug Goes Through Reverse Merger With Werewolf
Chronic pain biotech co-founded by Vivek Ramaswamy joins reverse merger train
Chronic pain biotech co-founded by Vivek Ramaswamy joins reverse merger train
Capricor investor calls for change as company awaits decision on Duchenne candidate
An investor pushes for strategic changes at Capricor Therapeutics as the company awaits an FDA decision on its Duchenne muscular dystrophy therapy candidate.
China IIT, Daichi Sankyo-AZ, Leo-Tanabe—Fierce Pharma Asia
China IIT, Daichi Sankyo-AZ, Leo-Tanabe—Fierce Pharma Asia
How Lundbeck’s CEO aims to keep firm ‘punching above its weight’
How Lundbeck’s CEO aims to keep firm ‘punching above its weight’
Novo Nordisk starts trialing lower maintenance doses of oral Wegovy
Novo Nordisk starts trialing lower maintenance doses of oral Wegovy
Pheast’s CEO has no regrets despite competitors gaining an edge
Pheast’s CEO has no regrets despite competitors gaining an edge
Regulatory tracker: J&J, Ono, LIB Therapeutics gain approvals
Regulatory tracker: J&J, Ono, LIB Therapeutics gain approvals
Trump taps White House aide Heidi Overton to lead FDA
Trump taps White House aide Heidi Overton to lead FDA
Boehringer again rises up rare disease reputation rankings
Boehringer again rises up rare disease reputation rankings
FDA Clearance of C2N Diagnostics' PrecivityAD2 Blood Test Advances Precision Medicine for Alzheimer's, Building on Groundwork Laid by Early ADDF Investment
FDA Clearance of C2N Diagnostics' PrecivityAD2 Blood Test Advances Precision Medicine for Alzheimer's, Building on Groundwork Laid by Early ADDF Investment
Moderna, Merck vaccine cuts recurrence and spread of melanoma, raising new treatment hope, includes video
Moderna, Merck vaccine cuts recurrence and spread of melanoma, raising new treatment hope, includes video
Net Health Launches Chart Audit in Optima Unity, Extending Native AI From Documentation to Compliance Review
Net Health Launches Chart Audit in Optima Unity, Extending Native AI From Documentation to Compliance Review
Renowned radiology innovator and longtime Subtle Medical advisor expands role to help advance the company's next generation of AI-powered imaging solutions
Renowned radiology innovator and longtime Subtle Medical advisor expands role to help advance the company's next generation of AI-powered imaging solutions
The global health aid architecture is collapsing. The faith economy isn’t
The global health aid architecture is collapsing. The faith economy isn’t
Ultragenyx bags first gene therapy approval as previously rejected Sanfilippo asset awaits decision
Ultragenyx bags first gene therapy approval as previously rejected Sanfilippo asset awaits decision
Xspray's Dasynoc knocked back by FDA over production once again
Xspray's Dasynoc knocked back by FDA over production once again
AI has created a shadow medical system
AI has created a shadow medical system
Human brain organoids model development for 5 years
Human brain organoids model development for 5 years
Trump taps White House aide as next FDA commissioner
Trump taps White House aide as next FDA commissioner
Trump’s FDA pick Overton good for psychedelics, new pain meds but bad for vaccines: Analysts
Trump’s FDA pick Overton good for psychedelics, new pain meds but bad for vaccines: Analysts
VIEW Moderna-Merck melanoma vaccine data boosts outlook, but analysts await full results
VIEW Moderna-Merck melanoma vaccine data boosts outlook, but analysts await full results
Biotech's reverse merger renaissance poised to continue
Biotech's reverse merger renaissance poised to continue
Consano Bio Receives FDA Fast Track Designation for C-1101 in Chronic, Painful Lumbosacral Radiculopathy (LSR) or Chronic Sciatica
Latest PR Newswire FDA coverage of Consano Bio Receives FDA Fast Track Designation for C-1101 in Chronic, Painful L
Enlil Unveils Governed AI Foundation to Ready Medical Device Makers for AI-Assisted Regulatory Review
Latest PR Newswire FDA coverage of Enlil Unveils Governed AI Foundation to Ready Medical Device Makers for AI-Assis
FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices
Latest FDA Newsroom coverage of FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enable
Leo Pharma to license Tanabe’s rare disease drug for pain with sun exposure
Leo Pharma to license Tanabe’s rare disease drug for pain with sun exposure
After 2 undisclosed deaths, can China’s IIT still be trusted?
Fierce Biotech raises questions about whether China's IIT (Investigator-Initiated Trial) pathway can still be trusted as an alternative regulatory path after two undisclosed gene therapy deaths.
Celcuity awaits FDA review for second factory to launch cancer drug
Endpoints News reports Celcuity is awaiting FDA review of a second manufacturing facility to support commercial launch of its cancer drug.
Evaxion scraps tumor vaccine to focus on brain cancer candidate
Fierce Biotech reports Evaxion scrapped its solid tumor vaccine program to focus on a Duke-partnered brain cancer candidate.
EyePoint's drug for age-related eye disease fails late-stage trial, shares tank
Reuters reports EyePoint's eye drug missed its main goal in a late-stage trial, sending shares tumbling.
EyePoint’s Phase 3 fail sends stock spiraling amid next-gen AMD race
BioSpace reports EyePoint Pharmaceuticals stock dropped sharply after its Phase 3 AMD drug failed, intensifying the next-generation macular degeneration competition.
Lilly to pay up to $370M for OmniAb collab; Slate, Fulcrum forge reverse merger
Endpoints News reports Eli Lilly will pay up to $370M to collaborate with OmniAb; separately, Slate and Fulcrum are forging a reverse merger to join Nasdaq with $245M for migraine trials.
Nolla Health Expands Medical Advisory Board and Clinical Leadership to Help Shape the Future of AI-Powered Healthcare
PR Newswire reports Nolla Health expanded its medical advisory board and clinical leadership team to advance its AI-powered healthcare platform.
Paid paternity leave is pediatric preventive care
Opinion piece arguing that paid paternity leave functions as preventive pediatric care.
Quanovate scratches marketing claims for Mira fertility wand
Latest Fierce Pharma coverage of Quanovate scratches marketing claims for Mira fertility wand
Sandoz to license three biosimilar drugs from Shanghai Henlius Biotech
Reuters reports Sandoz will license three biosimilar drugs from Shanghai Henlius Biotech, expanding its biosimilars portfolio.
Slate uses Fulcrum to join Nasdaq with $245M for migraine trials
Fierce Biotech reports Slate Medicines used Fulcrum Therapeutics' Vault reverse merger vehicle to join Nasdaq with $245M for migraine trials.
AbelZeta Regains Global Rights of C-CAR039 (Prizlon-cel) and Receives FDA Clearance of IND Application in Large B-cell Lymphoma
PR Newswire reports AbelZeta Pharma regained global rights to C-CAR039 (Prizlon-cel) and received FDA clearance of an IND application in large B-cell lymphoma.
Abcuro gets $66M for Phase 3 in muscle-weakening condition
Endpoints News reports Abcuro raised $66M to advance its Phase 3 program in a muscle-weakening condition.
Cytokinetics brings patent suit against Bristol Myers, escalating rivalry
Endpoints News reports Cytokinetics filed a patent infringement lawsuit against Bristol Myers Squibb, escalating competition in the cardiac myosin modulator space.
Lilly, PTC snap up bankrupt Sangamo's main assets
Just a few weeks after filing for bankruptcy protection, Sangamo has found buyers for some of its key assets, raising up to $85 million.
Novo Nordisk partners Amazon on London AI hub
Novo Nordisk has joined forces with Amazon Web Services (AWS) on a project that will lead to the creation of an AI co-innovation hub in London.
Redx tries again at reverse merger, with Skye this time, as alternative route gains steam
Endpoints News reports Redx Pharma is pursuing another reverse merger, this time with Skye Bioscience, as biotechs increasingly turn to alternative listing routes.
A genomics library for the AI era
Having spent 14 years building out its capacity, Regeneron Genetics Center—the genomic research branch of the Tarrytown, New York-based pharma—is a pro when it comes to the sort of target validatio | This week on "The Top Line," Fierce’s Fraiser Kansteiner sits down with Andy Deubler, chief business and administrative officer at Regeneron Genetics Center, to discuss the role RGC plays in the larger Regeneron model, as well as where the center could be headed as drug development pushes
ArkBio's RSV Antiviral Drug Ziresovir Receives FDA Approval for Phase II Clinical Trial
/PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the U.S. Food and Drug Administration (FDA) has approved ziresovir...
Bicara shakes up leadership ahead of CEO departure; J&J's John Reed joins Madrigal's board
Some big changes are coming at Bicara Therapeutics, and it starts at the top. President and COO Ryan Cohlhepp will take over as CEO on Jan. 1, and Claire Mazumdar will become vice chair.
Fierce Pharma Asia—Legend’s first profit; Taiho, Cullinan’s EGFR win; WuXi AppTec’s reprieve
As Legend Biotech became profitable, the company is navigating the next phase of growth for its flagship CAR-T therapy, Carvykti. | As Legend Biotech became profitable, the company is navigating Carvykti's next phase of growth. Taiho and Cullinan's EGFR candidate delivered a phase 3 win. WuXi AppTec won a preliminary injunction against the Defense Department's black list designation. And more.
MapLight presses the pause button; ADC Therapeutics considers what to do with Zynlonta
MapLight pauses preclinical work to focus on ML-007C-MA for schizophrenia; ADC Therapeutics weighs Zynlonta's future after FDA flags safety concerns in LOTIS-5 trial.
Ovid and Takeda's epilepsy drug gets new life at Perceptive-backed NewCo
Perceptive Advisors is launching a NewCo around soticlestat, Ovid Therapeutics and Takeda's failed epilepsy drug, with up to $294.5 million in milestones owed to Ovid.
Phanes Therapeutics Receives FDA Fast Track Designation for Spevatamig in Advanced and Metastatic Biliary Tract Carcinoma
/PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology,...
Aidoc's CARE Body CT Multi-Triage receives eligibility for Medicare New Technology Add-on Payment
/PRNewswire/ -- Aidoc today announced that the Centers for Medicare & Medicaid Services (CMS) has approved a New Technology Add-on Payment (NTAP) for the CARE™...
AZ's blood pressure newcomer Baxfendy fails to meet cost-effectiveness bar, ICER says
AstraZeneca’s newly approved, first-in-class hypertension drug Baxfendy does not clear the bar for effectiveness relative to its price, according to the Institute for Clinical and Economic Review ( | AstraZeneca’s newly approved blood pressure drug Baxfendy does not clear the bar for effectiveness relative to its price, according to U.S. drug price watchdog ICER.
Cancer vaccine win restores Wall Street’s faith in Moderna
Cancer vaccine win restores Wall Street’s faith in Moderna
Intermountain Health Brings Perimeter's Claire™ to the Operating Room, a Landmark in Breast Cancer Surgery Using AI
/PRNewswire/ -- Perimeter Medical Imaging AI, Inc. ("Perimeter" or the "Company") (TSXV: PINK) (OTCQX: PYNKF), a commercial-stage medical technology company,...
It's crunch time for Karyopharm as company faces potential default next month
With its reserves depleted, a debt payment due in four weeks and its cash runway stretching only into next month, the question for Karyopharm Therapeutics is what’s next and how soon can it happen? | With its reserves depleted, a debt payment due in four weeks and its cash runway stretching only into next month, the question for Karyopharm Therapeutics is what’s next and how soon can it happen? The company sustained a $67 million loss in the second quarter, which is greater than its current cash
Leo Pharma gears up for GPP awareness day
Abbott is again tapping into the competitive spirit of Big Ten universities to drive blood donations,
Neurocrine stands by blockbuster hopeful Vykat XR as Prader-Willi docs raise potential safety flags
Roughly a year and a half after the approval of Vykat XR, a group of clinicians with deep ties to the Prader-Willi syndrome (PWS) community is flagging potential safety concerns about the rare dise | Roughly a year and a half after the approval of Vykat XR, a group of clinicians with deep ties to the Prader-Willi syndrome (PWS) community is flagging potential safety concerns about the rare-disease med, acquired in Neurocrine’s $2.9 billion buyout of Soleno Therapeutics last spring.
Taiho and Cullinan’s zipalertinib clears Phase 3, teeing up first-line competition
Taiho and Cullinan’s zipalertinib clears Phase 3, teeing up first-line competition
Taiho and Cullinan secure lung cancer victory to challenge J&J
Taiho and Cullinan secure lung cancer victory to challenge J&J
Taiho, Cullinan's lung cancer drug passes Phase 3 test, lining up Rybrevant contest
Taiho, Cullinan's lung cancer drug passes Phase 3 test, lining up Rybrevant contest
Trump nominates policy aide Overton to lead FDA
Trump nominates policy aide Overton to lead FDA
Zealand's royalty deal; Khartis raises money for TED drug
Zealand's royalty deal; Khartis raises money for TED drug
After trimming headcount, Aardvark drops trials as wait drags on
After trimming headcount, Aardvark drops trials as wait drags on
AI clinical trial agent delivers up to 82 times ROI in oncology
AI clinical trial agent delivers up to 82 times ROI in oncology
Italian biotech gains momentum as VC funding, tech transfer environment improve
BioSpace reports Italian biotech companies are gaining momentum as VC funding and tech transfer environments improve.
Neuralytix Announces Full Commercial Availability of iD3 System for Intraoperative Nerve Assessment in Spine Surgery
Neuralytix Announces Full Commercial Availability of iD3 System for Intraoperative Nerve Assessment in Spine Surgery
Two health insurers give an AI reality check
Two health insurers give an AI reality check
With tech backing, AI biotechs force biopharma into ‘fail-fast’ drug development
With tech backing, AI biotechs force biopharma into ‘fail-fast’ drug development
Abbott, Google Health team up on AI-powered health insights app
Abbott, Google Health team up on AI-powered health insights app
Bristol Myers details new $2.3B manufacturing campus in Houston
Bristol Myers details new $2.3B manufacturing campus in Houston
Epicrispr, Infinimmune snag combined $165M in VC cash
Epicrispr Biotechnologies is working on an epigenetic medicine for facioscapulohumeral muscular dystrophy, while Infinimmune will advance a pair of antibodies for atopic dermatitis.
FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero™ Peripheral IVL System
FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero™ Peripheral IVL System
Leica Biosystems Enables Faster Cancer Diagnoses Through Multiple Digital Pathology FDA Clearances, Including Industry-First AI-Assisted Quality Control Software
Leica Biosystems Enables Faster Cancer Diagnoses Through Multiple Digital Pathology FDA Clearances, Including Industry-First AI-Assisted Quality Control Software
Lilly paid $2B upfront for vaccine biotechs; Infinimmune raises $75M
Lilly paid $2B upfront for vaccine biotechs; Infinimmune raises $75M
Neurolief Expands Veterans' Access to Prescription Neuromodulation for Depression and Migraine Through New VA Contract
Neurolief Expands Veterans' Access to Prescription Neuromodulation for Depression and Migraine Through New VA Contract
NIAID Awards Zepto Life Technology Contract Valued at Up to $8.9 Million to Advance the First Deployable Liquid Biopsy Platform for Infectious Disease
NIAID Awards Zepto Life Technology Contract Valued at Up to $8.9 Million to Advance the First Deployable Liquid Biopsy Platform for Infectious Disease
Novo Nordisk's Awiqli®, the first once-weekly basal insulin for adults with type 2 diabetes, now available in the US
Novo Nordisk's Awiqli®, the first once-weekly basal insulin for adults with type 2 diabetes, now available in the US
Scholar Rock rejigs approval filing after FDA flags violations at Novo plant
Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings.
AQUAPASS Completes Enrollment in REFORM-HF Pivotal Trial, Results to Be Presented at Major Heart Failure Conference This Fall
AQUAPASS Completes Enrollment in REFORM-HF Pivotal Trial, Results to Be Presented at Major Heart Failure Conference This Fall
As BMS’ Cobenfy struggles to gain traction, MapLight knocks on the door
As BMS’ Cobenfy struggles to gain traction, MapLight knocks on the door
How should states reach out to Medicaid enrollees affected by changes? Our research gives a hint
How should states reach out to Medicaid enrollees affected by changes? Our research gives a hint
Jazz bets on epilepsy again by acquiring Actio for $820M upfront
Jazz bets on epilepsy again by acquiring Actio for $820M upfront
Novo and Amazon sign drug discovery pact, launch innovation hub
Novo and Amazon sign drug discovery pact, launch innovation hub
Pathos AI signs two cancer deals with Alphamab and AZ
Pathos AI signs two cancer deals with Alphamab and AZ
Sionna’s cystic fibrosis failure is a windfall for Vertex’s blockbuster franchise
Sionna’s cystic fibrosis failure is a windfall for Vertex’s blockbuster franchise
Tenax shares nosedive as heart failure drug fails in Phase 3
Tenax shares nosedive as heart failure drug fails in Phase 3
FDA to hold adcomm for Grail cancer test that failed in large, randomized trial
FDA to hold adcomm for Grail cancer test that failed in large, randomized trial
Trump administration tries again to institute rebates in 340B
Trump administration tries again to institute rebates in 340B
Is the biotech capital of the world moving?
The STAT Readout newsletter explores Boston's biotech brain drain to Silicon Valley, a Medicare policy shift that could delay drug price negotiations, and new Alzheimer's tau research pointing toward novel therapeutic strategies.
Supernus, Indivior merge to beef up brain drug portfolio
Supernus, Indivior merge to beef up brain drug portfolio
Takeda, Daiichi, Astellas and more—Fierce Pharma Asia
Takeda, Daiichi, Astellas and more—Fierce Pharma Asia
Actimed recovers cachexia rights, ending $126M Faraday deal
Actimed Therapeutics has regained rights to its cachexia drug after terminating its $126 million deal with Faraday Pharmaceuticals.
BioVie stock halves on Parkinson's phase 2 readout
BioVie's stock fell by half after a Phase 2 readout in Parkinson's disease failed to impress, with the company pointing to a composite endpoint analysis.
Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test
Co-Diagnostics has submitted a dual 510(k) premarket notification, with a concurrent CLIA waiver request, to the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro instrument.
Double shot of Vistagen's anxiety nasal spray misses in ph. 2
Vistagen's anxiety nasal spray failed to beat placebo in two Phase 2 trials, another setback for the company's pipeline.
Greg Verdine’s LifeMine raises $263M for safer immunosuppressant
Greg Verdine’s LifeMine raises $263M for safer immunosuppressant
LifeMine revived by $188M fundraise backed by Gates and Bezos
LifeMine revived by $188M fundraise backed by Gates and Bezos
Sanofi asked to change Dupixent ads after Galderma challenge
Sanofi has been asked to change its Dupixent advertising after a challenge from Galderma over the campaign's claims.
U.S. moves to shut a Kentucky organ donation group, citing safety failures
The U.S. government is moving to shut down a Kentucky organ donation group accused of continuing plans for organ retrieval from some patients who unexpectedly showed signs of life.
Vectra AI Achieves FedRAMP High Authorization Through Partnership with Knox Systems, Bringing AI-Native Security to Federal Agencies
Vectra AI Achieves FedRAMP High Authorization Through Partnership with Knox Systems, Bringing AI-Native Security to Federal Agencies
ViiV targets 'future you' in long-acting HIV campaign
ViiV Healthcare is rolling out a new long-acting HIV campaign aimed at 'future you', promoting its long-acting treatment options.
Attovia's CEO aims to scratch itch opportunity with $289M IPO
Attovia Therapeutics aims to raise $289 million in an IPO to advance three immunology and inflammation drug candidates, including a bid to challenge Dupixent in itch.
Aveva Drug Delivery Systems prevails on appeal, Federal Circuit affirms non-infringement of ZTlido patents
The Federal Circuit affirmed a district court ruling that Aveva Drug Delivery Systems' generic ZTlido product does not infringe Scilex's patents, preparing the company for an imminent launch of its generic product with 180-day exclusivity.
Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad
Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad
LifeMine raises $263M in mission to improve organ transplant aftercare
Organ transplant biotech LifeMine Therapeutics has raised a combined $263 million — a $75 million Series D and an oversubscribed $188 million Series F — to support the clinical program for LIFE-001, under development to prevent organ failure.
Lilly beats forecasts again as tirzepatide makes up nearly two-thirds of revenue
Lilly beats forecasts again as tirzepatide makes up nearly two-thirds of revenue
Lilly drops another gene therapy trial from $1B Prevail buyout
Eli Lilly is dropping another gene therapy program acquired in its roughly $1 billion Prevail Therapeutics buyout, extending a series of portfolio reductions.
Lilly's $23B Q2 soars over expectations but Foundayo lags Novo's rival oral GLP-1
Eli Lilly delivered a big Q2 earnings beat with 48% revenue growth to $23 billion, though its oral GLP-1 candidate Foundayo trailed Novo Nordisk's rival pill.
Menu-Order AI Names Dr. Leigh-Anne Dale as Founding Medical Advisor
Menu-Order AI Names Dr. Leigh-Anne Dale as Founding Medical Advisor
Reckitt announces U.S. FDA approval of Mucinex 12HR Cold & Fever Multi-Symptom, the first OTC innovation in the cold & flu category in 14 years
Reckitt announced FDA approval of Mucinex 12HR Cold & Fever Multi-Symptom, the first and only FDA-approved OTC cold and flu medication that treats fever, cough, chest congestion and body pain for 12 hours — the company's first new drug approval.
Sanofi-backed Expedition lands $115M for ph. 2 COPD trial
Expedition Therapeutics raised $115 million to advance its lead oral DPP1 inhibitor EXPD-101 into a global Phase 2 COPD trial.
FDA expands Pluvicto label, making it available to most metastatic prostate cancer patients
FDA expands Pluvicto label, making it available to most metastatic prostate cancer patients
Gilead prevails in yearslong HIV drug innovation case
Gilead prevailed in a yearslong HIV drug innovation lawsuit after the California Supreme Court ruled drugmakers have no duty to innovate.
Icon inks Anthropic deal to deploy Claude into clinical trials
Contract research organization Icon has partnered with Anthropic to deploy its Claude AI assistant across clinical trial operations.
Jazz to withdraw Zepzelca in second-line small cell lung cancer
Jazz Pharmaceuticals will withdraw Zepzelca from the second-line small cell lung cancer setting after a confirmatory trial failure.
Latigo laces up for $247M IPO to fund rival to Vertex's Journavx
Latigo Biotherapeutics has set terms for a $247 million IPO to fund its non-opioid pain drug rival to Vertex's Journavx.
Lisata axes 72% of workforce following failed merger with Kuva
Lisata Therapeutics is cutting 72% of its staff and suing Kuva after their planned merger fell through.
Pathos inks back-to-back cancer contracts with AstraZeneca, China's Alphamab
AI-enabled oncology biotech Pathos AI signed back-to-back cancer deals with AstraZeneca and China's Alphamab worth up to $2.2 billion.
5 companies advancing ATTR assets in the wake of Wainua's fail
The Phase 3 failure of AstraZeneca and Ionis Pharmaceuticals' antisense therapy in transthyretin amyloid cardiomyopathy last month left the space reeling. BioSpace looks at five contenders advancing ATTR assets and where they stand.
Biotech leaders call for streamlining of INDs as FDA's Trialblazer rolls out
The FDA's new investigational new drug pilot program, part of HHS's broader clinical trial modernization initiatives, has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won't tip the scales alone.
Curium buys Lantheus for $8B; Sandoz settles price-fixing cases
Curium acquires Lantheus for $102.5/share (~$8B); Sandoz settles price-fixing claims for $478.5M; Latigo eyes a $247M IPO for non-opioid LTG-001; BlossomHill targets a $111M IPO.
Heart transplant candidates fail if they get too weak. New program tries inpatient prehab
Patients often get weaker waiting in the hospital for heart transplant. A cardiologist had an idea: inpatient prehabilitation.
Invenio Imaging Announces Completion of Enrollment in Landmark Study of AI-Based Image Analysis for Lung Cancer
Invenio Imaging, a leader in fresh tissue imaging and artificial intelligence, announced completion of patient enrollment in a landmark study of AI-based image analysis for lung cancer.
Novo's late-stage IL-6 stumble shakes inflammation space
Novo Nordisk was banking on the inflammatory benefits of its investigational therapy ziltivekimab to improve cardiovascular outcomes. Last week's Phase 3 failure dashed not just the Danish pharma's hopes but those of the broader inflammatio
Abcuro Adds $66M to Try Again in Rare Inflammatory Disorder With No Approved Drugs
Abcuro Adds $66M to Try Again in Rare Inflammatory Disorder With No Approved Drugs
AI in Drug Development is Not a Data Problem — It's An Evidence Problem
AI in Drug Development is Not a Data Problem — It's An Evidence Problem
Better Models Won't Fix Pharma's AI Problem — Better Terminology Will
Better Models Won't Fix Pharma's AI Problem — Better Terminology Will
Jazz Pharma Expands Again in Epilepsy With $820M Actio Bio Acquisition
Jazz Pharma Expands Again in Epilepsy With $820M Actio Bio Acquisition
Latigo Bio's IPO Lands $346M for Pipeline of Non-Opioid Pain Drugs
Latigo Bio's IPO Lands $346M for Pipeline of Non-Opioid Pain Drugs
Moderna Gets FDA Approval for mRNA Flu Vaccine, But CDC Input Still Uncertain
Moderna Gets FDA Approval for mRNA Flu Vaccine, But CDC Input Still Uncertain
Novo Nordisk rocked by late-stage cardiovascular drug failure
Novo Nordisk's cardiovascular pipeline suffered a late-stage clinical failure, a setback for the company's expansion beyond diabetes and obesity.
Pathos Picks Up Two Cancer Drugs Poised for Clinical Development With AI Agents
Pathos AI picked up two cancer drugs poised for clinical development, applying AI agents to drive the work forward.
PTC Therapeutics’ $211M Bid Wins Bankruptcy Auction for Sangamo Gene Therapy
Sangamo Therapeutics filed for Chapter 11 bankruptcy in June after its search for strategic alternatives failed to find a path forward for the company. PTC Therapeutics’ auction win brings a Sangamo gene therapy candidate for Fabry disease, a rare inherited disorder with few treatment options.
QuantHealth Snags $45M to Simulate Clinical Trials Before Patients Ever Enroll
QuantHealth raised $45 million to simulate clinical trials before patients ever enroll, applying AI to drug development.
Roche Gains Rights to Hanmi Obesity Drug That Reduces Fat, Preserves Muscle
Roche Gains Rights to Hanmi Obesity Drug That Reduces Fat, Preserves Muscle
Skyrizi's momentum defies J&J's rival Icotyde as AbbVie raises full-year sales guidance
AbbVie raised its full-year sales guidance on the strength of Skyrizi, whose momentum is holding up against Johnson & Johnson's rival drug Icotyde.
Slate Medicines' Merger and $245M Private Placement Fuel Mission in Migraine
Latest MedCity News coverage of Slate Medicines' Merger and $245M Private Placement Fuel Mission in Migraine
Vogenx IPO Raises $81M for Trial in Metabolic Disease With No Approved Drugs
MedCity News reports Vogenx raised $81M in its IPO to fund a clinical trial for post-bariatric hypoglycemia (PBH) with mizagliflozin, a metabolic disorder with no approved drugs.
Alnylam's slump deepens; Q2 earnings roundup; and more
Alnylam's stock slide deepened as the company reported second-quarter earnings, part of a broader biotech Q2 earnings roundup.
Apnimed raises $192M IPO for potential 2027 sleep apnea drug launch
Apnimed raises $192M IPO for potential 2027 sleep apnea drug launch
Capricor CEO won’t rule out legal action against FDA after negative adcomm
Capricor CEO won’t rule out legal action against FDA after negative adcomm
Chasing Vertex, Latigo reports non-opioid pain drug succeeds in key trial
Chasing Vertex, Latigo reports non-opioid pain drug succeeds in key trial
Daiichi Sankyo flags accounting error; shares tank
Daiichi Sankyo flags accounting error; shares tank
Eli Lilly is pharma’s latest victim of success
Reuters Breakingviews analyzes how Eli Lilly has become pharma's latest 'victim of success' as its growth strains capacity and pricing dynamics.
FDA panel endorses broader use of certain peptides
FDA panel endorses broader use of certain peptides
HIV resurgence looming as international aid declines
HIV resurgence looming as international aid declines
Ionis' top scientist Frank Bennett to retire; Recursion selects its first AI chief
Ionis' top scientist Frank Bennett to retire; Recursion selects its first AI chief
J&J nabs option to buy 'in vivo' CAR-T maker Sail for nearly $2.6B
J&J nabs option to buy 'in vivo' CAR-T maker Sail for nearly $2.6B
J&J takes $2.58bn option to buy in vivo CAR-T firm Sail
J&J takes $2.58bn option to buy in vivo CAR-T firm Sail
Novo’s IL-6 inhibitor fails in cardiovascular Phase 3, plunging shares more than 9%
Novo’s IL-6 inhibitor fails in cardiovascular Phase 3, plunging shares more than 9%
Pharma groups back changes to 340B rebate pilot as earlier version remains stuck in court
Pharmaceutical industry groups are backing revised terms for the 340B drug-pricing rebate pilot while an earlier version of the program remains tied up in litigation.
Syphilis spreads while researchers contend with federal constraints and a drug shortage
Syphilis spreads while researchers contend with federal constraints and a drug shortage
Trump's pharma tariffs won't kick in Friday because there's no one left to kick
The first round of tariffs on pharmaceutical imports is not starting as planned, with implementation stalling as the agencies tasked with enforcing them remain depleted.
We once praised the American Diabetes Association’s courage. How things have changed
We once praised the American Diabetes Association’s courage. How things have changed
Aspen Neuroscience Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Sasineprocel (ANPD001) to Treat Parkinson's Disease
Aspen Neuroscience Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Sasineprocel (ANPD001) to Treat Parkinson's Disease
AtaiBeckley attracted co-development and royalty offers before $2.8B Lilly deal
AtaiBeckley attracted co-development and royalty offers before $2.8B Lilly deal. Reported by Endpoints News on 2026-07-30.
Chronically ill people face confusion over new Medicaid work rules and ‘medically frail’ exemption
Chronically ill people face confusion over new Medicaid work rules and ‘medically frail’ exemption
CMS Validates Andor Health's AI-Native Clinical Services Operating Platform
CMS Validates Andor Health's AI-Native Clinical Services Operating Platform
Daiichi’s pipeline falls behind rivals as cash flow nears peak: analysts
Daiichi’s pipeline falls behind rivals as cash flow nears peak: analysts. Reported by BioSpace on 2026-07-30.
Ebola outbreak nears milestone, while a vaccine remains months away
Ebola outbreak nears milestone, while a vaccine remains months away. Reported by STAT News on 2026-07-30.
GSK, AI biotech Relation pen $110M biological datasets pact
GSK, AI biotech Relation pen $110M biological datasets pact
J&J lines up $2.58B option to buy Sail, Flagship's in vivo CAR-T biotech
J&J lines up $2.58B option to buy Sail, Flagship's in vivo CAR-T biotech. Reported by Endpoints News on 2026-07-30.
J&J secures right to take the helm in up to $925M Sail CAR T pact
J&J secures right to take the helm in up to $925M Sail CAR T pact. Reported by BioSpace on 2026-07-30.
Judge denies states’ motion to postpone Medicaid work requirement
Judge denies states’ motion to postpone Medicaid work requirement
New funding, new jobs: 4 biotechs hiring after series B raises
New funding, new jobs: 4 biotechs hiring after series B raises. Reported by BioSpace on 2026-07-30.
Replimune’s twice-rejected melanoma drug prevails in FDA adcomm
Replimune’s twice-rejected melanoma drug prevails in FDA adcomm
Ten years after WHO recognition, mycetoma remains one of the world’s most neglected diseases
Ten years after WHO recognition, mycetoma remains one of the world’s most neglected diseases. Reported by STAT News on 2026-07-30.
Teva CEO says there's time to prepare for Trump's tariffs on generics
Teva's CEO said the company has time to prepare for the incoming tariffs on generic drugs manufactured outside the U.S., expressing confidence in its ability to brace for the impact.
Caristo Diagnostics' CaRi-Heart Coronary Inflammation Technology Authorized by FDA
Caristo Diagnostics announced FDA authorization of its CaRi-Heart technology, an AI-powered coronary inflammation assessment tool that the company says identifies at-risk patients earlier than traditional imaging.
CG Life joins forces with The Considered+AI
Biopharma marketing agency CG Life merged with AI-driven branding firm The Considered+AI to broaden its AI capabilities for life-sciences clients.
Doctronic buys Summer Health, expanding into pediatric care
Doctronic acquired pediatric telehealth provider Summer Health to expand its AI-powered telehealth platform into pediatric care.
FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting
FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting. Reported by BioSpace on 2026-07-29.
FDA reminds investors that re-evaluations don't equal new conclusions
FDA officials reminded investors that re-evaluating existing data on a previously approved drug does not automatically produce new regulatory conclusions, pushing back against market expectations of imminent label changes.
FDA staff say Replimune's pivotal melanoma trial failed to prove RP1 works
FDA staff reviewers concluded that Replimune's pivotal melanoma trial failed to demonstrate that its oncolytic immunotherapy RP1 works, raising questions ahead of an advisory committee meeting.
J&J secures right to take the helm in up to $925M Sail CAR T pact
J&J secures right to take the helm in up to $925M Sail CAR T pact
KPM Analytics Introduces SiftAI FM HD Platform with Smarter AI, Enhanced Hygiene
KPM Analytics launched its SiftAI FM HD food and feed safety platform, featuring upgraded AI-based foreign-material detection and improved sanitary design for processing lines.
KPM Analytics Introduces SiftAI® FM HD Platform with Smarter AI, Enhanced Hygiene Design, and Clear Plastic Detection
KPM Analytics Introduces SiftAI® FM HD Platform with Smarter AI, Enhanced Hygiene Design, and Clear Plastic Detection
Leqembi records best quarter since launch as Biogen raises underlying guidance
Biogen's Leqembi recorded its best quarterly sales since launch as the Alzheimer's antibody continued to ramp, prompting the company to raise its underlying revenue guidance for the year.
Leqembi records best quarter since launch as Biogen raises underlying guidance
Leqembi records best quarter since launch as Biogen raises underlying guidance. Reported by Endpoints News on 2026-07-29.
Moderna maintains 10% growth target despite Phase 3 norovirus miss
Moderna maintains 10% growth target despite Phase 3 norovirus miss
Novo Nordisk fails to dismiss lawsuit over CagriSema readout
A federal judge denied Novo Nordisk's motion to dismiss a securities class action lawsuit over its 2024 CagriSema obesity-pipeline readout, allowing the case to proceed.
Novo ordered to face CagriSema fraud claims from shareholders: New Jersey court
Novo ordered to face CagriSema fraud claims from shareholders: New Jersey court. Reported by BioSpace on 2026-07-29.
NSF testing new Ph.D. model giving trainees academic and industry experience
NSF testing new Ph.D. model giving trainees academic and industry experience. Reported by STAT News on 2026-07-29.
NYU's Neil Vasan departs as acting chair of FDA's cancer drug advisory panel
NYU's Neil Vasan departs as acting chair of FDA's cancer drug advisory panel. Reported by Endpoints News on 2026-07-29.
PMCPA sanctions melatonin drugmaker over misleading information
The UK Prescription Medicines Code of Practice Authority ruled against a melatonin product manufacturer for misleading promotional claims, ordering the company to audit its materials.
Private biotechs Caldera and Vidya raise $478M collectively in reverse go-public mergers
Private biotechs Caldera and Vidya raise $478M collectively in reverse go-public mergers. Reported by BioSpace on 2026-07-29.
Teva's innovation engine offsets generic pressures
Teva executives said the company's branded and biosimilar growth plus cost discipline are offsetting continued generic price erosion in Q2.
Trace Biosciences Announces Strategic Investment from Axogen to Advance Clinical Pipeline
Trace Biosciences announced a strategic equity investment from Axogen to advance its nerve-repair clinical pipeline, with proceeds earmarked for an upcoming peripheral nerve regeneration trial.
Vertex's latest autoimmune TCE play involves $28M to AbCellera
Vertex paid AbCellera Biologics $28 million upfront under a new multi-target antibody discovery deal aimed at autoimmune T-cell engager (TCE) programs.
Viatris Receives U.S. FDA Approval for Gwyn Lo, a Once-Weekly Contraceptive Patch
Viatris announced FDA approval of Gwyn Lo, a once-weekly transdermal contraceptive patch, providing a new non-daily hormonal birth-control option.
As pharma descends on China for deals, BIOSECURE Act raises intellectual property risk
As pharma descends on China for deals, BIOSECURE Act raises intellectual property risk
Avenda Health's Unfold AI Enables AI-Guided Treatment Planning Across the Full Prostate Cancer Care Continuum
Avenda Health's Unfold AI Enables AI-Guided Treatment Planning Across the Full Prostate Cancer Care Continuum.
Cipla Receives U.S. FDA Approval for Generic Advair Diskus®
Cipla Receives U.S. FDA Approval for Generic Advair Diskus®.
Eli Lilly takes top spot on new biopharma productivity ranking
Eli Lilly claimed the top position in a new biopharma productivity ranking, ahead of AbbVie and Vertex, on revenue-per-R&D-dollar metrics.
FDA staff say Replimune's pivotal melanoma trial failed to prove RP1 works, pushing down stock
FDA staff say Replimune's pivotal melanoma trial failed to prove RP1 works, pushing down stock
FDA staff say Replimune's pivotal melanoma trial failed to prove RP1 works, pushing down stock
FDA staff say Replimune's pivotal melanoma trial failed to prove RP1 works, pushing down stock. Reported by Endpoints News on 2026-07-28.
FlyteHealth Achieves General Availability in the CMS Health Technology Ecosystem
FlyteHealth announced general availability of its digital obesity-care platform within the CMS Health Technology Ecosystem, broadening Medicare beneficiaries' access to GLP-1-supported care.
FlyteHealth Achieves General Availability in the CMS Health Technology Ecosystem, Recognized at One-Year Anniversary Event in Washington, D.C.
FlyteHealth Achieves General Availability in the CMS Health Technology Ecosystem, Recognized at One-Year Anniversary Event in Washington, D.C.
Gossamer regains rights to lung disease asset from Chiesi after Phase 3 fail
Gossamer regains rights to lung disease asset from Chiesi after Phase 3 fail.
GSK to start three-year plan to save cash, takes £1.33B hit on cough trial failure
GSK to start three-year plan to save cash, takes £1.33B hit on cough trial failure.
J&J proposes $5.5B deal to resolve 76,000 ovarian cancer claims
Johnson & Johnson proposed a $5.5 billion settlement to resolve roughly 76,000 lawsuits alleging its talc-based products caused ovarian cancer, the company's largest talc-related deal to date.
MapLight’s schizophrenia pill remains in Cobenfy’s shadow after mixed Phase 2 readout
MapLight’s schizophrenia pill remains in Cobenfy’s shadow after mixed Phase 2 readout.
New International Consensus Redefines Heart Failure Diagnosis, Putting Filling Pressure and Primary Care at the Center
New International Consensus Redefines Heart Failure Diagnosis, Putting Filling Pressure and Primary Care at the Center.
Parker Waichman Applauds Health Canada and Australia for Strengthening NAION Safety Guidance for Certain GLP-1 Medications
Parker Waichman Applauds Health Canada and Australia for Strengthening NAION Safety Guidance for Certain GLP-1 Medications.
AstraZeneca has no plans to ramp up dealmaking in wake of Wainua failure
AstraZeneca has no plans to ramp up dealmaking in wake of Wainua failure.
AstraZeneca looks to AI to ease risk in late-stage trials, speed up filings
AstraZeneca looks to AI to ease risk in late-stage trials, speed up filings.
BMS, NVIDIA to build 'most powerful' AI factory
BMS, NVIDIA to build 'most powerful' AI factory.
Lilly, AbbVie climb aboard in vivo CAR T train—but safety remains a hurdle
Lilly, AbbVie climb aboard in vivo CAR T train—but safety remains a hurdle.
Masimo Receives FDA 510(k) Clearance for the Pediatric Patient State Index, the First-and-Only Sedation Score Specifically Designed for the Unique Physiology of the Pediatric Brain
Masimo Receives FDA 510(k) Clearance for the Pediatric Patient State Index, the First-and-Only Sedation Score Specifically Designed for the Unique Physiology of the Pediatric Brain.
Summit, Merck must navigate new regulatory terrain in China-first cancer landscape
Summit, Merck must navigate new regulatory terrain in China-first cancer landscape.
UPDATE: FDA disputes Capricor’s claims of Phase 3 success for DMD cell therapy
UPDATE: FDA disputes Capricor’s claims of Phase 3 success for DMD cell therapy. Reported by BioSpace on 2026-07-27.
MapLight dives despite positive data for schizophrenia drug
MapLight Therapeutics shares dropped despite reporting positive topline Phase 2 data for its schizophrenia candidate, as investors focused on the commercial profile against existing antipsychotics.
Amgen shares new analysis with FDA in bid to keep Tavneos on the market
Amgen has submitted new analyses to the FDA in a bid to retain marketing authorization for Tavneos (avacopan) following agency concerns about the rare-disease drug's real-world performance.
Ipsen's Bylvay fails key trial in children with rare liver disease
Ipsen's Bylvay (odevixibat) failed a Phase 3 trial in biliary atresia, the latest setback for the Albireo portfolio acquired in 2021.
American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL Due to the Presence of Visible Particulate Matter
American Regent has issued a voluntary nationwide recall of one lot of papaverine hydrochloride injection after visible particulate matter was found.
FDA to end pilot aimed at preventing production issues
FDA to end pilot aimed at preventing production issues.
Ipsen's liver disease drug Bylvay fails biliary atresia trial
Ipsen's liver disease drug Bylvay fails biliary atresia trial.
Novo escalates legal fight with Lilly; J&J reinforces 'dominance' in multiple myeloma
Novo Nordisk has escalated its lawsuit against Eli Lilly over comparative ads, while J&J reinforces its dominance in multiple myeloma with new Tecvayli + Talvey data.
Novo escalates Lilly ad suit, plans bid to halt comparative ads
Novo Nordisk has escalated its false-advertising lawsuit against Eli Lilly, seeking a preliminary injunction to halt comparative ads.
Sanofi’s $1.4B Kymab bet falters again as atopic dermatitis trials scrapped
Sanofi’s $1.4B Kymab bet falters again as atopic dermatitis trials scrapped.
Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study.
The U.S. pharmaceutical supply chain problem is not about China
The U.S. pharmaceutical supply chain problem is not about China.
Roche drops lupus TCE, retains autoimmune cell therapy interest
Roche drops its lupus T-cell engager program but retains broader autoimmune cell therapy ambitions following pipeline review.
Roche says it is thoughtful on token use for AI, shelves a drug from Carmot buy
Roche says it is thoughtful on token use for AI, shelves a drug from Carmot buy.
Roche’s late stage pipeline ‘so full,’ CEO Schinecker not feeling pressure to add on
Roche has 19 investigational medicines that could launch by 2030—and even if not all of them make it to market, the company is “well set-up for growth into the next decade,” CEO Thomas Schinecker said on the pharma’s Q2 earnings call.
SimBioSys and Ferrum Health Partner to Expand Access to AI-Powered Surgical Planning Through Ferrum's AI Governance Suite
SimBioSys and Ferrum Health Partner to Expand Access to AI-Powered Surgical Planning Through Ferrum's AI Governance Suite.
SimBioSys and Ferrum Health Partner to Expand Access to AI-Powered Surgical Planning
SimBioSys and Ferrum Health partner to expand access to AI-powered surgical planning tools across U.S. hospitals.
VELMENI Receives FDA 510(k) Clearance for AI-Powered 3D CBCT Dental Imaging Software
VELMENI Receives FDA 510(k) Clearance for AI-Powered 3D CBCT Dental Imaging Software.
Venus Medtech annonce la fin du recrutement des patients dans le cadre de l'essai clinique décisif mené en Chine sur le Venus Powerx, le premier système TAVR au monde à valve sèche, auto-expansible et entièrement récupérable
Venus Medtech annonce la fin du recrutement des patients pour l'essai clinique chinois de Venus Powerx.
Venus Medtech Announces Completion of Patient Enrollment in Pivotal China Trial for Venus-PowerX, the World's First Fully Recoverable Self-Expanding Dry-Valve TAVR System
Venus Medtech Announces Completion of Patient Enrollment in Pivotal China Trial for Venus-PowerX, the World's First Fully Recoverable Self-Expanding Dry-Valve TAVR System.
Venus Medtech Announces Completion of Patient Enrollment in Pivotal China Trial for Its Self-Expanding Transcatheter Pulmonary Valve
Venus Medtech announces completion of patient enrollment in a pivotal China trial for its transcatheter pulmonary valve technology.
Agios Pharma Drops Sickle Cell Disease Drug After Phase 2 Data Disappoint
Agios Pharmaceuticals said tebapivat fell short of expectations in a Phase 2 test in sickle cell disease.
AI data becomes sticking point in biopharma dealmaking
As drug hunting gets more complex, where and how data is generated in partnerships between Big Pharmas and AI biotechs is becoming a headache for dealmakers.
Crystalys gets $130M to take Sobi-rivaling gout drug to market
Crystalys raised $130M to advance its Sobi-rivaling gout drug through Phase 3 testing.
Crystalys nets $130M more to push gout drug through late-stage tests
Crystalys raised $130M to push its gout drug dotinurad through late-stage testing.
Crystalys mines $130M series B to push gout drug through phase 3
Crystalys raised a $130M series B to push its gout drug through phase 3 testing.
Dimension restocks with $800M to capitalize on AI's 'rapid ascent'
Dimension raised $800M for its third fund to capitalize on AI's 'rapid ascent' in biotech.
Kaken details the data behind its PI3K inhibitor filing
Kaken has revealed the data that supported its recent marketing application for serabelisib as a treatment for vascular malformations in Japan.
Mentari adds $200M to migraine mission; Royalty's latest ATTR-CM deal
Mentari raised $200M for its migraine program while Royalty Pharma announced a new ATTR-CM deal.
NIH joins Trump's $5B AI mission with biomedical research push
NIH joins the White House's $5B artificial intelligence "Genesis Mission" with a biomedical research push and expanded AI compute.
Precision Neuro breaks new ground in BCI technology
Precision Neuroscience has shown that people can control electronic devices with thought alone, without electrodes implanted in the brain.
Thiel-backed CEO eyes $50M fundraise after bagging China drug
Ashlins Pharma has licensed a Chinese formulation of a well-known medicine and set its sights on a $50 million fundraise.
Sanofi gets FDA untitled letter over Beyfortus promotional emails
Sanofi receives an FDA untitled letter calling out Beyfortus (nirsevimab) promotional emails as misleading.
Summit updates ivonescimab survival data ahead of PDUFA
In the latest ivonescimab survival data, 'most western patients have now discontinued treatment or completed two years of treatment,' Summit said.
Ukraine Ministry of Health Accepts Entolimod Dossier for Formal Review Under Regulatory Equivalence Pathway
Valion Bio announced that Ukraine's Ministry of Health accepted the Company's regulatory dossier for Entolimod.
Wainua flop narrows AstraZeneca's path to $80B goal ahead of high-risk readouts
With a Phase 3 failure denting the rare disease drug's prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.
Agios axes next-gen sickle cell candidate after it fails to best Novo’s asset
Agios axes next-gen sickle cell candidate after it fails to best Novo’s asset.
Agios says adios to sickle cell program over lackluster Phase 2 data
Agios said adios to its sickle cell program over lackluster Phase 2 data.
Bristol Myers to build 'powerful' AI factory; Samsung Biologics bids for peptide maker
Bristol Myers Squibb announced it would build a 'powerful' AI factory, while Samsung Biologics bids for peptide maker PolyPeptide.
Broad Institute launches Center for Therapeutic Genetics for rare diseases
Broad Institute launches Center for Therapeutic Genetics for rare diseases.
Compounders maintain a firm grip on the GLP-1 market
Compounders maintain a firm grip on the GLP-1 market despite FDA crackdown and pharma lawsuits.
Gilead, Merck phase 3 data back first weekly HIV pill
Gilead, Merck phase 3 data back first weekly HIV pill.
GSK shelves cough drug acquired in $2B deal
GSK is shelving its cough drug camlipixant that it acquired in a $2 billion deal.
House lawmakers rally behind trade probe of China biotech market
House lawmakers are rallying behind a trade probe of U.S. biotech firms' exposure to Chinese sequencing and genomics supply chains.
Is there an exodus underway at Epic?
Is there an exodus underway at Epic?
J&J, AbbVie said to have also looked at AtaiBeckley before Lilly’s $2.8B deal
J&J, AbbVie said to have also looked at AtaiBeckley before Lilly’s $2.8B deal.
Jupiter enters psychedelics space with $100M deal for MDMA drug
Jupiter enters psychedelics space with $100M deal for MDMA drug.
Pain drugmaker Latigo outlines plans to go public
Pain drugmaker Latigo outlined plans to go public on NASDAQ under ticker LTGO.
Lilly to buy AtaiBeckley for $2.8B, further validating psychedelics
Eli Lilly agreed to buy AtaiBeckley for $2.8 billion, further validating psychedelics research.
Lupin seeds US spinout with cash, clinical-stage cancer assets
Lupin seeds US spinout with cash, clinical-stage cancer assets.
Moderna says CureVac broke agreement by suing over COVID vaccine patents
Moderna says CureVac broke agreement by suing over COVID vaccine patents.
New center launches for personalized genetic therapies
New center launches for personalized genetic therapies.
Notes from a peptide meetup
Notes from a peptide meetup.
Novartis CEO shrugs off oral PCSK9 threat amid Q2 growth
Novartis CEO shrugs off oral PCSK9 threat amid Q2 growth.
Novartis drops ph. 2-stage radioligand therapy over poor data
Novartis drops ph. 2-stage radioligand therapy over poor data.
Novartis stays ‘geography-agnostic’ in dealmaking amid flurry of China deals
Novartis stays ‘geography-agnostic’ in dealmaking amid flurry of China deals.
Novo accuses Lilly of running ‘false and misleading’ GLP-1 ads
Novo accuses Lilly of running ‘false and misleading’ GLP-1 ads.
Samsung Bio to expand its wheelhouse in $1.8B buy for peptide API maker
Samsung Bio to expand its wheelhouse in $1.8B buy for peptide API maker.
Science and the public are learning the wrong lessons from Covid
Science and the public are learning the wrong lessons from Covid.
Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab
Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab.
Tempus to acquire cancer test maker Personalis for $1.5B
Tempus AI agreed to acquire cancer test maker Personalis for $1.5 billion.
THC drinks are sold beside sodas, iced tea, and even chocolate milk, often in violation of state laws
THC drinks are sold beside sodas, iced tea, and even chocolate milk, often in violation of state laws.
The FDA's 505(b)(2) pathway is an underestimated engine of value creation
BioSpace's contributor column argued that the FDA's 505(b)(2) regulatory pathway remains an underestimated engine of value creation for biopharma companies repurposing approved drugs.
Trump administration says it’s deferring $1B in Medicaid payments to California and Minnesota
Trump administration says it’s deferring $1B in Medicaid payments to California and Minnesota.
UnitedHealth Group lays out progress in AI push
UnitedHealth Group lays out progress in AI push.
Why Novartis CEO ended his ADC holdout for $1.5B Myricx deal
Novartis CEO explained why he ended his ADC holdout for the $1.5B Myricx deal.
Why US biotech Axiom is starting its IPO journey in Hong Kong
Why US biotech Axiom is starting its IPO journey in Hong Kong.
2026 IPO class blooms again as BlossomHill, Latigo set sights on Nasdaq
2026 IPO class blooms again as BlossomHill, Latigo set sights on Nasdaq.
Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs
Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs.
Bayer's Kerendia on course for NHS use in heart failure
Bayer's Kerendia on course for NHS use in heart failure.
BMS, Nvidia aim for ‘most powerful AI factory in life sciences’
BMS, Nvidia aim for ‘most powerful AI factory in life sciences’.
Bristol Myers says it will build pharma's 'most powerful' AI supercomputer with Nvidia
Bristol Myers says it will build pharma's 'most powerful' AI supercomputer with Nvidia.
FDA’s radical transparency policy for rejections runs into legal uncertainty
FDA’s radical transparency policy for rejections runs into legal uncertainty.
J&J, Time to name Healthcare Champion of the Year
J&J, Time to name Healthcare Champion of the Year.
Kolon’s cell-based gene therapy fails ph.3 osteoarthritis test
Kolon’s cell-based gene therapy fails ph.3 osteoarthritis test.
Lilly buys into psychedelics with $3.8bn AtaiBeckley deal
Lilly buys into psychedelics with $3.8bn AtaiBeckley deal.
Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics
Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics.
Rebel Wilson talks losing weight 'for keeps' in Noom campaign
Rebel Wilson talks losing weight 'for keeps' in Noom campaign.
Samsung Bio set to launch $1.8B buyout of Swiss CDMO PolyPeptide
Samsung Bio set to launch $1.8B buyout of Swiss CDMO PolyPeptide.
Sanofi survey reveals diabetes misconceptions and screening gaps
Sanofi survey reveals diabetes misconceptions and screening gaps.
Scribe aims for $96M IPO to fund lipid-lowering genetic meds
Scribe aims for $96M IPO to fund lipid-lowering genetic meds.
Why Legend Biotech stock fell 10% despite record Carvykti sales
Why Legend Biotech stock fell 10% despite record Carvykti sales.
Midsized biotechs take case against CMS' GLOBE and GUARD models to White House
Midsized biotechs take case against CMS' GLOBE and GUARD models to White House.
ANF Care™ Brings New Wearable Technology to the United States
ANF Care announced US market entry for its ANF Care wearable therapeutic device, expanding availability of its frequency-based wearable technology to American patients and clinicians.
Can ultrasound unlock the power of gene therapy? A startup makes big claims
Sonathera claims ultrasound can unlock the power of gene therapy in Duchenne and other diseases.
GSK culls cough program for drug at the heart of $2B Bellus bet after Phase 3 fail
GSK discontinues its Phase 3 chronic cough program from the $2B Bellus Health acquisition.
Novo, Alvotech written up after FDA site inspections
FDA disclosed concerns raised during recent visits to manufacturing sites tied to Novo and Alvotech.
FDA rejects Hengrui-Elevar liver cancer drug combo for third time
FDA rejects Hengrui-Elevar liver cancer drug combo for third time.
FDA returns to releasing pharma rejection letters with 14 new CRLs
FDA returns to releasing pharma rejection letters with 14 new CRLs.
FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturers
FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturers
FDA's first AI-focused cGMP warning letter signals new scrutiny for manufacturers
FDA issues its first AI-focused cGMP warning letter, signaling new scrutiny for drug manufacturers.
HoneyNaps Receives U.S. FDA 510(k) Clearance for SOMNUM V3.0 for AI-Based Sleep-Disordered Breathing Analysis
HoneyNaps Receives U.S. FDA 510(k) Clearance for SOMNUM V3.0 for AI-Based Sleep-Disordered Breathing Analysis
How well are AI-discovered drugs faring in the clinic?
BioPharma Dive survey of how AI-discovered drugs from Insilico, Recursion, Verge are faring in the clinic.
Huahai poaches quality chief from Hengrui amid FDA citations
Huahai hires Hengrui's quality chief amid FDA manufacturing citations.
Lilly bets $2.8B upfront on psychedelics in deal to buy AtaiBeckley
Lilly bets $2.8B upfront on psychedelics in the AtaiBeckley acquisition.
Lilly bets $2.8B upfront on psychedelics in deal to buy AtaiBeckley
Lilly bets $2.8B upfront on psychedelics in the AtaiBeckley acquisition.
Lilly inks $2.8B AtaiBeckley psychedelic buyout to challenge J&J
Lilly inks $2.8B AtaiBeckley psychedelic buyout to challenge J&J
Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeover
Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeover
Nobel Laureate Jennifer Doudna enters AI protein design arena
Jennifer Doudna enters the AI protein design arena with a new venture.
Raidium Brings AI-Powered Oncology Imaging Workflow to US Cancer Centers
Raidium Brings AI-Powered Oncology Imaging Workflow to US Cancer Centers
Updated: Radiopharma maker AdvanCell hauls in $315M for Pluvicto challenger
Radiopharma maker AdvanCell raises $315M for a Pluvicto challenger.
US drug shortages rise for third straight quarter, hurt by lone suppliers
US drug shortages rise for third straight quarter, hurt by lone suppliers.
AAIC 2026: Anti-tau space begins to clarify as Biogen presents detailed data on antisense drug
New mid-stage data from Biogen's Ionis-partnered therapy diranersen validates the tau hypothesis in Alzheimer's disease.
AISAP Named a Featured Case Study in New WHO Report on AI in Healthcare
AISAP Named a Featured Case Study in New WHO Report on AI in Healthcare
Amid $55B US manufacturing push, J&J turns to streamlining its pharma supply chain
Amid $55B US manufacturing push, J&J turns to streamlining its pharma supply chain
Biogen data highlight promise, questions surrounding tau-targeting Alzheimer's drugs
Biogen's tau-targeting Alzheimer's data shows promise but raises questions about dose response.
Biogen validates anti-tau approach at AAIC, psychedelics full speed ahead, ATTR-CM shakeup
Biogen validates anti-tau approach at AAIC, psychedelics full speed ahead, ATTR-CM shakeup
Bora inks $2.5B deal with drug discovery AI specialist Insilico
Bora inks $2.5B deal with drug discovery AI specialist Insilico
Celcuity gains FDA approval for closely watched breast cancer drug
Celcuity gains FDA approval for the closely watched breast cancer drug Revtorpyk (gedatolisib).
Graham’s death from aortic dissection raises questions about preventing the rare disorder
Graham’s death from aortic dissection raises questions about preventing the rare disorder
Insilico, Bora Pharma reveal plans for AI-driven manufacturing company
Insilico, Bora Pharma reveal plans for AI-driven manufacturing company.
MAXONA PHARMACEUTICALS RECEIVES FDA IND CLEARANCE FOR MAX-001 PHASE 2 ACUTE PAIN CLINICAL TRIAL
MAXONA PHARMACEUTICALS RECEIVES FDA IND CLEARANCE FOR MAX-001 PHASE 2 ACUTE PAIN CLINICAL TRIAL
Post-Hoc Live: What's making biotech IPOs work again?
Post-Hoc Live panel discusses what's making biotech IPOs work again.
Q2 earnings arrive as pharma picks up steam, buoyed by dealmaking, policy tailwinds
Q2 earnings arrive as pharma picks up steam, buoyed by dealmaking, policy tailwinds
Q32 bounces back to claim study success for alopecia drug
Q32 bounces back to claim study success for alopecia drug
Standing out, not blending in: how AI tools can drive impact during job searches
Standing out, not blending in: how AI tools can drive impact during job searches. Reported by BioSpace on 2026-07-15.
The biggest career decisions don't feel like career decisions
BioSpace's career-advice column argued that the biggest career decisions rarely feel like career decisions in the moment, but instead emerge as accumulation of smaller daily choices over time.
UK price watchdog recommends against Amgen's Lumakras in lung cancer
UK price watchdog recommends against Amgen's Lumakras in lung cancer.
Veradermics keeps 'momentum going' as baldness drug helps women with hair loss
Veradermics reports female-pattern hair loss results for its oral minoxidil baldness drug.
Veradermics reports ph. 2 win in female pattern hair loss
Veradermics reports ph. 2 win in female pattern hair loss
With $315M raise, AdvanCell puts radiotherapy pedal to the metal
With $315M raise, AdvanCell puts radiotherapy pedal to the metal
Alcohol Health Issues: Deadliest Drug Series Final Installment Solutions
A STAT News series finale examines alcohol as the deadliest drug and surveys policy solutions to address harmful consumption.
AstraZeneca, Ionis drug fails big heart disease study in major setback
AstraZeneca, Ionis drug fails big heart disease study in major setback
Caris Life Sciences Expands Precision Oncology in Metastatic Prostate Cancer with PTEN IHC Testing
/PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading patient-centric next-generation AI TechBio company and precision medicine pioneer, today...
Chai brews up $400M series C to fuel AI used by Lilly and Pfizer
Chai brews up $400M series C to fuel AI used by Lilly and Pfizer
Chai Discovery gets $400M, tripling valuation from seven months ago
Chai Discovery raises $400M, tripling its valuation in seven months.
Draig bags another $65M to speed testing of brain drugs
Draig bags another $65M to speed testing of brain drugs
Draig nets $65M to advance depression drug aimed at rebuilding synapses
Draig raises $65M to advance a depression drug aimed at rebuilding synapses.
FDA approves at-home starter dose of Eisai-Biogen Alzheimer's drug, includes gallery
FDA approves at-home starter dose of Eisai-Biogen Alzheimer's drug, includes gallery
FDA proposes to streamline registration of drugmakers' foreign and US factories
FDA proposes to streamline registration of drugmakers' foreign and US factories.
Majority of new Ebola cases in eastern Congo are from unknown chains, as outbreak outpaces response
Majority of new Ebola cases in eastern Congo are from unknown chains, as outbreak outpaces response
Newronika Receives CE Mark for αDBS®, Advancing Its Mission to Make Adaptive Therapy the Standard of Care
/PRNewswire/ -- Newronika S.p.A., the Milan-based medtech company redefining deep brain stimulation therapy, has received CE Mark certification for the latest...
Real Chemistry builds body of AI tools with Anatomi launch
Real Chemistry builds body of AI tools with Anatomi launch
Summit sells failed antibiotic to OpenAI-backed startup
Summit sells failed antibiotic to OpenAI-backed startup
The future of pain relief: Exploring opioid alternatives
BioSpace feature on emerging opioid alternatives for pain relief.
AB Science ends 3 studies in multiple sclerosis, other immune conditions
The trials, which were testing the tyrosine kinase inhibitor masitinib, had previously been paused. AB Science’s decision not to resume them was a matter of prioritization, not safety, the biotech said. AB Science is formally terminating three studies for immune-mediated diseases in what it characterizes as an effort to better focus the biotech’s resources on its priority programs. The French company is axing a mid-stage study in mast cell activation syndrome (MCAS), a late-stage trial in mastoc
Agenus scraps ph. 3 colorectal study to narrow focus to colon
Agenus has scrapped a phase 3 study of its combo therapy in colorectal cancer after just three months in order to go all-in on colon cancer. The biotech launched the late-stage Battman study in April to evaluate a combination of its CTLA-4 inhibitor botensilimab and an anti-PD-1 antibody balstilimab in unresectable microsatellite stable (MSS) metastatic colorectal cancer (mCRC). The aim was to enroll 830 patients across Canada, France, Australia and New Zealand.
AstraZeneca takes another China trip, picking Dizal’s lung cancer drug for up to $1.5B
Dizal Pharmaceutical’s Zegfrovy is approved in the U.S. for locally advanced or metastatic non-small cell lung cancer. For $600 million upfront, AstraZeneca will gain global rights to advance and commercialize the asset.
Biogen, Eisai win FDA nod for starter dose of subcutaneous Leqembi
Biogen, Eisai win FDA nod for starter dose of subcutaneous Leqembi
Exit of Roche’s embattled Huntington’s drug ‘tightens’ case for Wave’s more selective ASO
The failure of Roche’s Ionis-partnered tominersen in Huntington’s disease may indicate that Wave Life Sciences’ allele-specific antisense oligonucleotide candidate WVE-003 is on the right track, according to analysts at Rodman & Renshaw.
FDA posts new rejection letters days after confirming pause
The FDA last week confirmed that it would suspend the release of complete response letters pending the resolution of a citizen petition from an unnamed pharma company. Nevertheless, 14 new CRLs are now available on the agency’s portal. Just days after it confirmed a temporary suspension to its public disclosure of complete response letters, the FDA seems to have uploaded another batch of such documents to its online portal.
FDA proposes streamlined requirements for ‘hub-and-spoke’ manufacturing models
Through the proposal, the FDA could clear barriers to distributed manufacturing approaches intended to enhance emergency preparedness and supply chain resilience.
Germany approves controversial healthcare reform package
Even as the effort has met with fierce pushback from drugmakers, trade groups and opposition parties in the country’s own government, German lawmakers late Friday voted to pass health insurance reforms aiming to cut healthcare costs next year, in part by hiking up mandatory rebates that pharmas must pay on branded medicines. Still, previous resistance appears to have spared the pharmaceutical industry from at least one negative outcome in the central European nation, which often serves as a prov
GSK to seek FDA approval for Jemperli in high-profile cancer use
In what GSK says represents a potential way to transform treatment for patients with certain types of rectal cancer, the company’s Jemperli has met the main goal of a phase 2 trial, teeing up an application with the FDA. Interim results from the phase 2 AZUR-1 study showed a “meaningful and sustained” clinical complete response rate for Jemperli at 12 months in stage 2/3 mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer, GSK said Monday.
Insilico’s partner pens $177M pact for ‘mass market’ CNS target
Insilico Medicine Licensing deals central nervous system China Pharma platform company China Medical System Holdings (CMS) has tapped up existing partner Insilico for a 1.2 billion yuan ($177 million) collaboration aimed at a “mass-market” central nervous system (CNS) indication. The pact will involve Insilico’s AI platform PandaOmics joining forces with CMS’ “experienced R&D team and deep therapeutic expertise,” according to the July 12 release. While the companies didn’t divulge the specific C
Island Pharma drug cleared for Bundibugyo Ebola use
Island Pharma drug cleared for Bundibugyo Ebola use Island Pharma has been granted the regulatory approvals needed to allow compassionate use of its antiviral galidesivir in the Bundibugyo Ebola outbreak in Uganda. The Melbourne, Australia-based biotech said it expects galidesivir to be deployed in the country this year, giving it an opportunity to generate "prospective human efficacy, safety and virological data" during an active outbreak of an Ebola virus species.
NICE aims to cut funding for Amgen lung cancer drug Lumykras
NICE aims to cut funding for Amgen lung cancer drug Lumykras Lumykras, which is known as Lumakras in some markets, will no longer be covered by the Cancer Drugs Fund, according to the health technology assessment (HTA) agency. Amgen has reacted with consternation to the news that treatment with its KRAS inhibitor Lumykras will no longer be funded in England and Wales, saying the decision does not reflect experience with the lung cancer therapy since it was first made available four years ago.
NICE backs NHS use of non-invasive endometriosis tests
NICE backs NHS use of non-invasive endometriosis tests Women with endometriosis in England could soon be offered simple non-invasive tests for diagnosis of their condition, rather than a diagnostic laparoscopy, a surgical procedure that is costly and carries risk. The debilitating condition – where tissue similar to the lining of the womb grows elsewhere in the body – affects one in 10 women of reproductive age in the UK, and causes symptoms like pain and extreme tiredness and, if untreated, can
Q32’s stock jumps 60% on latest phase 2 alopecia data
The latest phase 2 readout for Q32 Bio’s alopecia hopeful received a warm reception from investors, backing up the biotech’s claim that the drug could offer a more durable alternative to JAK inhibitors. The data, released Monday morning, come from part B of the Signal-AA study, which enrolled 33 patients with severe or very severe alopecia areata to receive the anti-IL-7R antibody bempikibart. Patients received a 200-mg subcutaneous dose weekly for four weeks, followed by 200 mg every other week
Top emerging biotech hubs in 2026
When it comes to centers for biotech innovation and expansion, well-established locations such as Boston and South San Francisco have long dominated the field. But in the last few years, an array of other cities have emerged to stake their claim by offering government incentives, new developments, a lower cost of living and other advantages. These regions hope to ride the wave of the life sciences industry’s increased prominence since the pandemic. That attention has helped spark a global real e
UK first in Europe to clear Boehringer's IPF drug Jascayd
UK first in Europe to clear Boehringer's IPF drug Jascayd Boehringer Ingelheim has the first European approval for its new idiopathic pulmonary fibrosis (IPF) therapy, Jascayd, after the UK's MHRA gave a green light to the drug. Phosphodiesterase (PDE) 4B inhibitor Jascayd (nerandomilast) has been cleared as a twice-daily, oral therapy for adults with IPF as well as progressive pulmonary fibrosis (PPF), an umbrella term for diseases caused by progressive scarring to the lungs.
Apnimed dreams of IPO to fund launch of sleep apnea pill
Apnimed is having sweet dreams of an IPO that could fund the planned commercial launch of an obstructive sleep apnea (OSA) therapy that is currently awaiting an FDA approval decision. The therapy, called Oxnimbi or AD109, is a drug combination that targets a cause of upper airway collapse in people with OSA. Apnimed reported two phase 3 wins for AD109 in 2025 and submitted an approval application to the FDA in April this year.
Biotechs forced to learn new patent tricks to protect pipelines
For a biotech, your intellectual property is your most prized asset. But a new era of increased global competition means that strong patents, longer stealth periods and even some misdirection can be required to ensure drug developers retain an edge. A growing source of competition is China, where science can move quickly and cheaply. The Asia Society—a global organization dedicated to understanding Asia’s role in the world—reported last year that Chinese biotechs recruit trial patients two to th
AstraZeneca, Ionis’ Wainua woes send waves across ATTR-CM space
BioSpace reports: AstraZeneca, Ionis’ Wainua woes send waves across ATTR-CM space.
AZ's China deals, Kailera-Hengrui—Fierce Pharma Asia
Fierce Pharma reports: AZ's China deals, Kailera-Hengrui—Fierce Pharma Asia.
Bausch + Lomb gives up on glaucoma eye drop hopeful after fail
Fierce Biotech reports: Bausch + Lomb gives up on glaucoma eye drop hopeful after fail.
Bayer scores €3B capital equity infusion in deal with Apollo
Bayer has agreed to a €3 billion capital and equity infusion from Apollo for a stake in its contraceptives business, providing balance-sheet support amid ongoing litigation and pipeline pressure.
Wall Street ends higher as investors turn to earnings season, includes video
Wall Street ends higher as investors turn to earnings season, includes video.
Young people with PKU take the mic in BioMarin podcast series
BioMarin is amplifying teen voices living with phenylketonuria (PKU) through a podcast series and TikTok campaign, aiming to build community around its rare-disease franchise.
AstraZeneca, Ionis slip as ATTR-CM drug fails Phase 3
AstraZeneca, Ionis slip as ATTR-CM drug fails Phase 3 (BioSpace.)
AstraZeneca's Wainua fails key heart disease trial, shares tumble
AstraZeneca's Wainua fails key heart disease trial, shares tumble
Biotech M&A is accelerating. Track the deals that are happening here.
In the business of drug development, deals can be just as important as scientific breakthroughs. Many of today’s most lucrative medicines, from the life-saving cancer treatment Keytruda to the anti-inflammatory agent Enbrel, might not have become so without mergers and acquisitions. The end of the last decade brought record highs in pharmaceutical M&A as larger companies turned again and again to young biotechs for innovation. Often, these deals focused on cancer, rare diseases and immune system
GSK ends brain drug alliance with Alector
BioPharma Dive reports: GSK ends brain drug alliance with Alector.
Ipsen’s Botox rival Dysport posts dual ph. 3 wins in migraine
Ipsen’s Botox rival Dysport posts dual ph. 3 wins in migraine (Fierce Pharma.)
Kailera says obesity pill succeeds in late-stage trial in China
BioPharma Dive reports: Kailera says obesity pill succeeds in late-stage trial in China.
Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal
BioPharma Dive reports: Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal.
Psychedelics surge again as Compass, Definium provide more clinical validation
BioSpace reports: Psychedelics surge again as Compass, Definium provide more clinical validation.
Affordable Care Act insurers want more premium increases as enrollment sags
Affordable Care Act insurers want more premium increases as enrollment sags (STAT News.)
Amgen recalls almost 1 million bottles of heart failure drug over quality issue
Amgen recalls almost 1 million bottles of heart failure drug over quality issue (reported by BioSpace)
Hengrui, Kailera’s oral GLP-1 clears late-stage bar in China but US results still pending
Hengrui, Kailera’s oral GLP-1 clears late-stage bar in China but US results still pending (reported by BioSpace)
Lundbeck hit with untitled letter over Vyepti efficacy claims
Lundbeck hit with untitled letter over Vyepti efficacy claims (Fierce Pharma.)
Novartis slashes New Jersey workforce again, cutting 322 employees
Novartis slashes New Jersey workforce again, cutting 322 employees (reported by BioSpace)
Satellos’ ‘intriguing’ DMD data raise hopes ahead of key readout
Satellos’ ‘intriguing’ DMD data raise hopes ahead of key readout (reported by Fierce Biotech)
Secretive AI drug hunter Xaira dips toe into dealmaking with hunt for partners
Secretive AI drug hunter Xaira dips toe into dealmaking with hunt for partners (reported by BioSpace)
Trial results set up Keenova to gain 3rd indication for Xiaflex
Trial results set up Keenova to gain 3rd indication for Xiaflex (Fierce Pharma.)
Vertex carries M&A uptick into H2, IPOs and VC raises also grow, FDA on pace despite turmoil
Vertex carries M&A uptick into H2, IPOs and VC raises also grow, FDA on pace despite turmoil (reported by BioSpace)
AI care partner Heidi touts positive side effects in campaign
AI care partner Heidi touts positive side effects in campaign (reported by Fierce Pharma)
BMS details Krazati confirmatory fail in colorectal cancer
BMS details Krazati confirmatory fail in colorectal cancer (reported by Fierce Pharma)
Caidya and Simbec-Orion unite in global CRO combo
Caidya and Simbec-Orion unite in global CRO combo (reported by Fierce Biotech)
FDA Clears CliniComp PACS Viewer (MIMPS), Unifying Diagnostic Imaging, Enterprise EHR, and Native AI in a Single Platform
FDA Clears CliniComp PACS Viewer (MIMPS), Unifying Diagnostic Imaging, Enterprise EHR, and Native AI in a Single Platform (reported by PR Newswire)
Presage Technologies Earns FDA Clearance for Contactless Vital Signs, Makes Them Available for Free
Presage Technologies Earns FDA Clearance for Contactless Vital Signs, Makes Them Available for Free (reported by PR Newswire)
Hair loss biotech Veradermics, up 656% since its IPO, credits the obesity boom
Hair loss biotech Veradermics, up 656% since its IPO, credits the obesity boom (reported by BioSpace)
Anthropic launches Claude Science for pharma researchers
Anthropic launches Claude Science for pharma researchers. (Pharmaphorum.)
AstraZeneca pays CSPC $30M to form kidney drug discovery pact
AstraZeneca pays CSPC $30M to form kidney drug discovery pact — Fierce Biotech coverage of biopharma industry developments.
After landmark deal, AstraZeneca goes to CSPC again in up to $1.7B pact
After landmark deal, AstraZeneca goes to CSPC again in up to $1.7B pact — Endpoints News coverage of biopharma industry developments.
AstraZeneca taps China’s CSPC again, betting up to $1.77B to target kidney diseases
AstraZeneca taps China’s CSPC again, betting up to $1.77B to target kidney diseases. (BioSpace.)
Pfizer appoints obesity discovery head; AI startup Xaira makes leadership adjustments
Pfizer appoints obesity discovery head; AI startup Xaira makes leadership adjustments.
When clinical AI gets real
When clinical AI gets real — Endpoints News coverage of biopharma industry developments.
A $1B Acquisition Gives Novartis a Way to Stand Out in Crowded Area of Cancer
Myricx Bio brings to Novartis antibody drug conjugates with a novel cancer-killing payload called an NMT inhibitor. Novartis says Myricx’s drugs could have advantages over currently available ADCs as well as those still in clinical development.
After Antibiotic Approval, Spero Pivots to Immunology Aiming to Rival an Amgen Asset
After Antibiotic Approval, Spero Pivots to Immunology Aiming to Rival an Amgen Asset
Expecting Massive Test Growth in Cancer & More, Tempus AI Strikes $1.5B Deal to Buy Personalis
Expecting Massive Test Growth in Cancer & More, Tempus AI Strikes $1.5B Deal to Buy Personalis.
Glaucoma Drug Fails Trial, But Bausch + Lomb Sees Opportunity in Another Eye Disease
Glaucoma Drug Fails Trial, But Bausch + Lomb Sees Opportunity in Another Eye Disease
Haleon joins the AI deal wave with Microsoft collab
Haleon joins the AI deal wave with Microsoft collab. (Fierce Pharma.)
J&J Joins Immune Reset Race, Paying $785M to Partner on Sail Bio Cell Therapy
J&J Joins Immune Reset Race, Paying $785M to Partner on Sail Bio Cell Therapy
Lilly Expands Its Mind to Psychedelics With $2.8B AtaiBeckley Acquisition
Lilly Expands Its Mind to Psychedelics With $2.8B AtaiBeckley Acquisition.
Lung-Focused Celea Secures $180M for Pivotal Test of Pulmonary Fibrosis Drug
Celea Therapeutics raises $180M to fund a pivotal clinical trial of its lead idiopathic pulmonary fibrosis drug candidate. (Source: MedCity News, 2026-07-01)
Old cancer drug may help restore fertility for certain women
Old cancer drug may help restore fertility for certain women
Phase 3 Failure Keeps AstraZeneca and Ionis Out of a Growing Heart Disease Market
Phase 3 Failure Keeps AstraZeneca and Ionis Out of a Growing Heart Disease Market
Sarepta secures early 2027 FDA decision for Duchenne drugs, pushing past confirmatory fail
Sarepta secures early 2027 FDA decision for Duchenne drugs, pushing past confirmatory fail — BioSpace coverage of biopharma industry developments.
Tenpoint brings blurry vision hassles to life in new campaign
Tenpoint brings blurry vision hassles to life in new campaign. (Fierce Pharma.)
The Measurement Problem Behind Two Decades of Neurology Trial Failures
The Measurement Problem Behind Two Decades of Neurology Trial Failures
The top biopharma conferences remaining in 2026
The top biopharma conferences remaining in 2026. (BioPharma Dive.)
Vistagen in freefall as social anxiety drug fails Phase 3
Vistagen in freefall as social anxiety drug fails Phase 3 — BioSpace coverage of biopharma industry developments.
Why Pharma Companies Should Look To Social Media For Better Patient Insight
Why Pharma Companies Should Look To Social Media For Better Patient Insight.
With New Phase 3 Data, Roche Claims an Edge Over Amgen and BMS Lung Cancer Drugs
With New Phase 3 Data, Roche Claims an Edge Over Amgen and BMS Lung Cancer Drugs — MedCity News coverage of biopharma industry developments.
With New Phase 3 Data, Roche Claims an Edge Over Amgen and BMS Lung Cancer Drugs
With New Phase 3 Data, Roche Claims an Edge Over Amgen and BMS Lung Cancer Drugs (MedCity News.)
Bain-backed Angitia drops lead spinal fusion candidate
Bain-backed Angitia drops lead spinal fusion candidate — Fierce Biotech coverage of biopharma industry developments.
Beeline adds $126M to Bain-backed immunology pipeline from Bristol Myers
Beeline adds $126M to Bain-backed immunology pipeline from Bristol Myers
Evommune ends development of lead asset in chronic hives after mid-stage efficacy woes
Evommune is discontinuing development of its lead chronic spontaneous urticaria candidate after a mid-stage trial failed to meet efficacy benchmarks.
Klick bags Oxford PharmaGenesis in 3rd takeover in 18 months
Klick Health acquired UK-based medical communications firm Oxford PharmaGenesis, the third takeover in 18 months as the agency expands its global medical-affairs footprint.
The top biopharma conferences remaining in 2026
The top biopharma conferences remaining in 2026 (BioPharma Dive.)
After trial fail, Teravance is bought out by Zymeworks for $929M
Zymeworks is acquiring Theravance Biopharma in a $929 million deal, taking out the struggling drugmaker after a Phase 3 failure of its lead respiratory candidate.
Evommune's lead drug fails in chronic hives, stock sinks
Endpoints News reports that Evommune's lead clinical candidate failed to meet primary endpoints in chronic hives, sending shares down on the readout.
FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
The FDA announced the seven participants in its PreCheck Pilot Program, which is designed to streamline regulatory pathways and incentivize domestic pharmaceutical manufacturing.
BIO 2026: AI, federal policy impacts, and general vibes
BIO 2026: AI, federal policy impacts, and general vibes (STAT News.)
BIO 2026: Making biotech IPOs great again and the forgotten pharma antitrust review
BIO 2026: Making biotech IPOs great again and the forgotten pharma antitrust review
EC begins antitrust probe into Sanofi's flu shot campaign
EC begins antitrust probe into Sanofi's flu shot campaign.
EU Commission opens antitrust probe into Sanofi's flu vaccine campaign
EU Commission opens antitrust probe into Sanofi's flu vaccine campaign
EU Hits France's Sanofi With Flu Vaccine Antitrust Probe
European Commission launched an antitrust investigation into Sanofi over concerns it pursued a misleading communication campaign to disparage Fluad by portraying it as inferior to Efluelda.
FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health
The FDA proposed a new rule targeting foreign tobacco product manufacturers, aiming to close regulatory gaps and strengthen enforcement against non-compliant imported products.
Jails are the frontline in fielding dangerous new type of drug withdrawal
Jails are the frontline in fielding dangerous new type of drug withdrawal.
Lycia raises $75M for food allergy and Graves’ disease
Lycia raises $75M for food allergy and Graves’ disease
Aidoc Receives FDA Breakthrough Device Designation for AI That Drafts Radiology Reports Aidoc, the clinical AI company support
Aidoc Receives FDA Breakthrough Device Designation for AI That Drafts Radiology Reports Aidoc, the clinical AI company support
Bipartisan bill seeks to allow direct prescribing of methadone for opioid addiction
Methadone for opioid addiction has been available only at specialty clinics. A bipartisan bill would greatly expand access.
Recordati licenses Ionis drug; Vaxart's BARDA funding is cut
Daily briefs: Recordati licenses Ionis' zilganersen for ex-US rights; Vaxart's BARDA award cut by $116M; plus Leyden Labs, Otsuka, Pfizer and Hutchmed.
SCOTUS ruling blunts state-level claims against Bayer's Roundup
SCOTUS ruling blunts state-level claims against Bayer's Roundup.
Supreme Court ruling blocks thousands of lawsuits against maker of Roundup weedkiller
Supreme Court ruling blocks thousands of lawsuits against maker of Roundup weedkiller.
AbbVie keeps M&A rolling, FDA’s reversal train chugs along, BIO 2026 dispatch, more
AbbVie scooped up immunology player Apogee Therapeutics for nearly $11 billion in one of the year’s top deals to-date, while Sanofi made a big play to survive its upcoming Dupixent patent cliff; FDA uncertainty continues as the agency changes direction on gene therapies by uniQure and REGENXBIO;…
BIO 2026: US needs to dodge China’s ‘inescapable dependencies’ to protect biotech
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
FDA hiring 2,200 people to staff up after last year’s DOGE cuts
The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Icon names Microsoft tech partner as Q1 results grow analyst confidence
Irish CRO giant ICON this week made Microsoft its technology partner as the organization advances its plan to increase investment in AI over the next three years. | Irish CRO giant Icon this week made Microsoft its technology partner as the organization advances its plan to increase investment in AI over the next three years. Microsoft’s Copilot and data infrastructure will be implemented enterpri
Mapp, Gilead antivirals to be deployed in DRC Ebola trial: WHO chief
As health officials grapple with a fast-moving outbreak of the Bundibugyo ebolavirus in the Democratic Republic | Officials are planning to study Mapp Biopharmaceutical’s MBP134 and Gilead Sciences’ remdesivir, which gained prominence during the COVID-19 pandemic, against the Bundibugyo ebolavirus.
Ollin Biosciences Announces Oversubscribed $330M Series B Financing
Ollin Biosciences raised $330M in an oversubscribed Series B to advance global Phase 3 development of OLN324 in DME and wet AMD, studies commencing in second half of 2026.
Ollin parlays Vabysmo beat into $330M raise to test eye disease drug in Phase 3
With positive feedback on a Phase 3 trial design, Ollin Biosciences has collected a $330 million series B to advance its VEGF/Ang2 antibody, which bested Genentech’s therapy in a head-to-head study.
UK biotech secures $115M to advance portfolio of virus-targeting antibodies
RQ Bio has clinched $115 million in a Series A raise to advance a preclinical pipeline of virus-targeting antibodies.
US military requires flu vaccine for some after outbreak in Texas training center
US military requires flu vaccine for some after outbreak in Texas training center. (Reuters Biopharma.)
Whoop dodges FDA enforcement action
The FDA said it will not take enforcement action against Whoop, nearly a year after it warned the wearable maker over its blood pressure tracker.
A different kind of AI entrant in healthcare
A different kind of AI entrant in healthcare.
EU probes Sanofi for alleged smear campaign against rival flu vaccine
EU probes Sanofi for alleged smear campaign against rival flu vaccine.
Exclusive: Brent Saunders' latest dermatology bet gets $20M for skin longevity
Brent Saunders' latest dermatology startup raised $20M to develop skin longevity therapeutics, marking his return to the specialty he built Allergen around.
Exclusive: Flagship's Abiologics uses AI to build mirror-image proteins for new drugs
Flagship Pioneering's Abiologics emerged from stealth, using AI to design mirror-image proteins as a new modality for drug development.
Exelixis' TKI falls short in colorectal cancer subgroup as FDA reviews approval in all-comers
Exelixis' zanzalintinib (TKI) failed to meet the dual primary endpoint in a subgroup of patients with previously treated metastatic colorectal cancer who did not have active liver metastases, despite numerical improvement in overall survival.
Genentech, Novartis accused of Xolair kickback scheme in lawsuit
A whistleblower lawsuit accuses Genentech and Novartis of running a decades-long kickback scheme around the allergic asthma drug Xolair.
HHS details plan to regain the US's edge in clinical trials
HHS details plan to regain the US's edge in clinical trials.
Judge rules government can't stop SNAP dollars from buying candy and sugary drinks
The federal government can't block benefits from the nation's largest food aid program from being used to buy candy, soda, and other sugary drinks, a judge ruled.
Nuvectis, Haisco ink up to $1.4B deal for two late-stage programs
Nuvectis Pharmaceuticals signed a deal worth up to $1.4B with Haisco Pharmaceutical for two late-stage oncology programs.
Pfizer delivers ‘disappointing’ late-stage lung cancer data for ADC from $43B Seagen buy
Despite an overall survival miss, Leerink Partners said Pfizer’s antibody-drug conjugate showed “promising” signals of efficacy in a subgroup of patients who had undergone only one prior line of treatment.
Pfizer's $43B Seagen bet sours further as ADC fails in late-stage lung cancer trial
Pfizer's $43B Seagen acquisition faced another setback as a key ADC failed in late-stage lung cancer trials, raising fresh questions about the deal's strategic value.
Texas doctor charged in $89M fraud case as administration pushes health care crackdown
Federal prosecutors charged a Texas doctor in an $89M healthcare fraud case as the Trump administration intensifies its crackdown on Medicare and Medicaid fraud.
The Catch-22 for disabled workers hidden in Medicaid's new work requirements
New Medicaid work requirements create a Catch-22 for disabled workers who lack medical proof of their disability, threatening to strip them of coverage.
UPDATE: Lilly, Astellas circle Sangamo assets as biotech files for bankruptcy
Sangamo Therapeutics will lay off 51 members of its workforce while retaining 77 people to continue work on the programs central to Astellas and Eli Lilly's bids.
With onshoring ‘having a moment,’ Aquestive CEO shares lessons from 20 years of US manufacturing
Having stuck with local production in the years when offshoring to lower-cost locations was in fashion, Aquestive’s CEO is well placed to explain what the recent reshoring drive means for manufacturers.
AbbVie inks $10.9B Apogee buyout to bag eczema prospect
Fierce Biotech reports AbbVie is acquiring Apogee Therapeutics for $10.9B to gain control of a late-phase eczema drug candidate that could compete with Lilly, Regeneron, and Sanofi.
Swoop Acquires Nimble, Adding Prescription Fulfillment and Pharmacy Connectivity to Portfolio
Swoop Acquires Nimble, Adding Prescription Fulfillment and Pharmacy Connectivity to Portfolio.
AH-008 Achieves Dual Regulatory Milestones with U.S. FDA IND Clearance and Taiwan CDE Index Case Designation AnHorn Medicines
AH-008 Achieves Dual Regulatory Milestones with U.S. FDA IND Clearance and Taiwan CDE Index Case Designation AnHorn Medicines
Alnylam scolded over promotional activity after Pfizer complaint
Alnylam Pharmaceuticals faces regulatory scrutiny over promotional practices following a complaint by Pfizer.
Alnylam scolded over promotional activity after Pfizer complaint
Alnylam drew regulatory scrutiny over its promotional activity after a complaint from Pfizer, highlighting ongoing tension between innovators and generic / biosimilar competitors.
Insilico's AI design engine bags Korean biotech deal worth possible $2.5B+
Insilico Medicine signs a deal with a Korean biotech to use its AI-driven drug design engine, with biobucks potentially exceeding $2.5 billion.
BioArctic and Lilly sign research and collaboration agreement combining Lilly compound with BioArctic's BrainTransporter technology
BioArctic and Lilly sign research and collaboration agreement combining Lilly compound with BioArctic's BrainTransporter technology.
Lilly bets up to $800M for BioArctic’s brain delivery tech
Eli Lilly plans to use BioArctic’s technology to shuttle an undisclosed drug candidate into the brain. The pharma hasn’t specified which neurodegenerative disease it will target.
MapLight Announces Topline Results from Phase 2 IRIS Study for ML-004 in Autism Spectrum Disorder
MapLight Therapeutics announced topline results from the Phase 2 IRIS study of ML-004 (a novel mechanism) in autism spectrum disorder. Despite Phase 2 results, the company is engaging with FDA on the path forward for the program.
Nura raises $73.8M to target ALS through a unique target
Nura Bio will use the series B financing to carry two neuroprotective drug candidates through early- to mid-stage clinical studies, one targeting ALS and the other for a broader neurological profile.
Sanofi's R&D head exits, with AI biotech Xaira's exec stepping in
Sanofi loses its R&D head to AI biotech Xaira Therapeutics, which is contributing its executive to the pharma giant.
MapLight Announces Topline Results From Phase 2 IRIS Study for ML-004
MapLight Announces Topline Results From Phase 2 IRIS Study for ML-004.
Inside Pfizer's $10B deal with Innovent: a 5-month sprint
Fierce Biotech details the rapid-fire negotiations behind Pfizer's $10 billion deal with Innovent Biologics.
Denali sells FDA voucher for $195M to support neurodegenerative pipeline
Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.
FDA's new voucher program hints at broader policy agenda, making many 'uncomfortable'
Experts say the FDA Commissioner's National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency's senior leaders topping the list.
Memento brings home $93M Series A souvenir, picks up bispecific for eye diseases
Memento raises $93M in Series A funding and in-licenses a bispecific antibody for ophthalmology indications.
No investors. A 50/50 split everyone warned us against. How Endpoints survived its first decade — and ended up at the FT
No investors. A 50/50 split everyone warned us against. How Endpoints survived its first decade — and ended up at the FT.
US launches investigation into German drug pricing, citing unfair R&D burden
The U.S. government has argued that it pays too much of biopharma R&D costs, demanding that other high-income countries contribute fairly to global innovation efforts.
AI’s growing appetite for power is a public health issue. Here’s a fix
AI’s growing appetite for power is a public health issue. Here’s a fix.
At FDA, 'caretaker mode' is better than power trip mode
FDA acting commissioner Kyle Diamantas approves uniQure's Huntington's gene therapy path while keeping the agency in a 'caretaker' posture, raising questions about long-term durability of flexible decisions once a permanent commissioner is seated.
Eli Lilly cuts hospitals' 340B pricing over data policy dispute
Eli Lilly is cutting 340B drug pricing to hospitals that fail to comply with its claims data policy.
Exclusive: Lilly's TuneLab crosses 100-member mark, adds AI models from buzzy startup Chai
Lilly's TuneLab AI platform has crossed the 100-member mark and added AI models from Chai.
'Familiarity' with oral Wegovy has triggered its quick uptake
Spherix data shows Novo Nordisk's oral Wegovy pill is being adopted rapidly because of prescriber and patient 'familiarity' with the semaglutide class, accelerating uptake against Lilly's Foundayo.
Insilico Medicine And SK Biopharmaceuticals Achieved AI-powered Drug Discovery Collaboration Worth Potential $2.5B+
Insilico Medicine and SK Biopharmaceuticals achieved a major AI-powered drug discovery collaboration worth potentially $2.5 billion+, leveraging Insilico's AI drug discovery platform to develop novel therapeutics.
Kardigan Announces Pricing of Upsized Initial Public Offering
Kardigan's common stock began trading on the Nasdaq Global Market on June 18, 2026, under ticker KARD, with the offering expected to close on June 22, 2026.
Novocure device fails to improve brain cancer patients' survival in Phase 3 test
Novocure device fails to improve brain cancer patients' survival in Phase 3 test.
Ones to watch: 4 biotechs with recent Series B raises (that are also hiring)
Four biotechs that closed recent Series B financings are actively hiring across R&D, clinical, and operations roles as they scale toward lead asset milestones.
Prepping for peptides
The pharmaceutical industry is racing to prepare peptide manufacturing capacity as GLP-1 demand and a wave of next-gen peptide therapies strain existing production infrastructure.
RA, Forbion and Sanofi Ventures appear to back new eye drug from Korea
RA Capital, Forbion and Sanofi Ventures are backing a new Korean ophthalmology biotech developing a novel eye drug, with financing details expected to be announced in the coming weeks.
Be Bio bins hemophilia B cell therapy trial-the biotech's lead program
Be Bio discontinues its lead hemophilia B cell therapy program after a clinical review, raising questions about the company's engineered B cell platform strategy and pipeline direction.
Edgewise slides as cardiomyopathy challenger to BMS, Cytokinetics falls short
Edgewise Therapeutics' lead cardiac myosin modulator underwhelmed in a Phase 2 readout, sending shares lower and raising doubts about its competitive standing against BMS and Cytokinetics in the HCM space.
Hackers Claim Responsibility for Novo Nordisk Cyberattack
Hackers Claim Responsibility for Novo Nordisk Cyberattack.
Triveni Bio raises $65M ahead of upcoming readouts on eczema drugs
Triveni Bio raises $65M ahead of upcoming readouts on its eczema drug programs, advancing its antibody-based pipeline for immune and inflammatory diseases.
UK waitlist for Novo's Wegovy pill triples in week after approval, major online pharmacy says
Waitlist for Novo Nordisk's oral Wegovy in the UK has tripled in the week following MHRA approval, per a major online pharmacy, signaling strong consumer demand for the pill form.
UniQure plans Q3 submission for Huntington’s gene therapy after FDA reverses course—again
After a regulatory odyssey that delayed a filing for what would be the first genetic medicine for Huntington’s disease, the FDA has agreed that three-year data from uniQure’s Phase 1/2 trial are sufficient to support an accelerated biologics license application.
Vedana Therapeutics Launches With $46 Million Series A Financing
Vedana Therapeutics emerged from stealth with $46M Series A financing (co-led by Westlake BioPartners and Canaan Partners) to advance next-generation therapies for migraine prevention.
Big Pharma's 10 highest-paid CEOs of 2025
Fierce Pharma's annual ranking of the top 10 highest-paid CEOs among big pharmaceutical companies for 2025, including total compensation packages and stock awards.
Exclusive: UCSF spinout Kopra Bio nets $9.1M to test virus therapy for brain cancer in China
Kopra Bio, a UCSF spinout developing viral immunotherapy for glioblastoma, has raised $9.1M to begin a China clinical trial of its InViTE platform that uses genetically engineered viruses to selectively destroy tumor cells.
FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
The FDA expanded access to over-the-counter naloxone nasal spray, making the opioid-overdose reversal agent more widely available without a prescription.
FDA, MHRA strengthen transatlantic alliance with liaison program
The FDA and the UK's MHRA announced a new liaison program to deepen transatlantic regulatory cooperation, including shared reviews and joint inspections.
Lilly bolsters non-opioid pain portfolio with 4E Therapeutics buy
Lilly bolsters non-opioid pain portfolio with 4E Therapeutics buy.
Verge Labs Unveils vBx: A Breakthrough Foundation Model for Precision Neurology
Verge Labs (formerly Verge Genomics) has unveiled vBx, a new foundation model designed for precision neurology. The model leverages Verge's multi-modal human tissue database to solve patient stratification problems for neurology clinical trials.
CMS seeks to close Medicare negotiation 'loophole'
The Centers for Medicare & Medicaid Services has proposed a rule to close a loophole in the Medicare drug price negotiation program that some manufacturers have used to delay negotiations.
Eisai Gets UK Backing as It Expands Plant for Leqembi Production
Eisai is expanding its UK packaging and manufacturing footprint for Leqembi with a £65M government-backed investment, securing capacity for the Alzheimer's antibody as global demand ramps post-FDA approval.
Elicio's KRAS Cancer Vaccine Fails in Phase 2, Shares Plummet
Elicio Therapeutics' KRAS-targeted cancer vaccine failed to meet its primary Phase 2 endpoint in metastatic pancreatic cancer, sending shares down more than 60% and forcing a strategic review of the platform.
Elicio Crashes on Midstage Pancreatic Cancer Miss But Will Advance to Phase 3
Elicio Therapeutics' KRAS-targeted cancer vaccine missed its Phase 2 primary endpoint in pancreatic cancer, cratering the stock, but the company said it will still advance the program to a Phase 3 trial based on a subpopulation signal.
Germany scraps variable discount plan meant to cut costs: report
Germany has scrapped a planned variable discount pricing scheme aimed at cutting drug costs, marking a reversal after industry pushback and parallel concerns from companies like Lilly and Boehringer Ingelheim.
Funding: HMNC and the Long Road to Precision Psychiatry
Funding: HMNC and the Long Road to Precision Psychiatry.
Funding: HMNC and the Long Road to Precision Psychiatry
Funding: HMNC and the Long Road to Precision Psychiatry.
How Does Ibogaine Work? Understanding Matrix Logic to Make a Safer Drug
Researchers are using matrix logic and modern receptor pharmacology to design safer ibogaine analogs that retain the psychedelic's anti-addiction potential while avoiding the cardiac and neurotoxicity risks of the parent compound.
Despite FDA Trial Clearance, Ibogaine Metabolite Won't Receive Red Carpet Treatment
DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for the controversial psychedelic despite a long history of safety concerns and a still-cautious FDA posture.
IQVIA Taps AI to Put Overlooked Prescribers on Marketers' Maps
IQVIA is rolling out an AI-driven prescriber identification tool designed to surface community physicians and nurse practitioners whose prescribing patterns are routinely missed by traditional pharma targeting models.
Lilly sees quick return on $2.3B Ajax buy as blood cancer drug shows early efficacy
Eli Lilly’s new JAK2 inhibitor—which it obtained from the recent acquisition of Ajax Therapeutics—reduced spleen volume by more than a third in 70% of patients with myelofibrosis.
Neumora Discards Depression Asset, Lays Off Staffers After Pair of Late-Stage Flops
Neumora Therapeutics is laying off 35% of its workforce and discontinuing its lead depression drug after the asset failed two Phase 3 trials, sending shares down sharply and forcing a major pipeline reset.
Neumora discards depression asset, lays off staffers after pair of late-stage flops
Neumora discards depression asset, lays off staffers after pair of late-stage flops.
FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients With Stage 3 Type 1 Diabetes
The FDA has approved Sanofi's type 1 diabetes therapy Tzield (teplizumab) for children with stage 3 disease, expanding the disease-modifying treatment to a much younger patient population.
ADA: AstraZeneca Hands Structure a Win With 'Relatively Underwhelming' GLP-1 Pill Data
Structure Therapeutics' oral GLP-1 pill produced a 'relatively underwhelming' but still positive Phase 2 readout in diabetes, with analysts questioning commercial viability against Lilly's Foundayo and Novo's Wegovy pill.
ADA: Lilly Bests Novo Again, Takes GLP-1 Pill Foundayo to FDA for Diabetes Approval
Eli Lilly has submitted Foundayo, its oral GLP-1 receptor agonist, to the FDA for diabetes approval on the strength of head-to-head Phase 3 data presented at ADA showing superior A1C reduction versus Novo Nordisk's Wegovy pill.
Astellas, Takeda, RA Capital: This Week in Asia-Pacific Pharma
Astellas laid out a five-year strategic plan, Takeda's TYK2 inhibitor beat BMS's Sotyktu in a head-to-head psoriasis trial, and RA Capital launched a new China bridge program. Fierce Pharma Asia's weekly roundup of the region's most consequential biopharma moves.
Parabilis Medicines IPO Prices at $20 per Share, Raising $670M
Parabilis Medicines IPO Prices at $20 per Share, Raising $670M.
Biopharma Sentiment Index | Q2 2026
The Q2 2026 Endpoints Biopharma Sentiment Index shows industry confidence continuing its 2026 rebound, with sentiment rising across small-molecule, biologics, and AI-driven drug discovery subsectors.
Biotech Stocks Are on a Tear Again: Signal Insights
Endpoints Signal Insights recaps the latest biotech stock surge, with the XBI hitting multi-year highs on the back of strong IPOs, M&A activity, and policy stability after a brutal 2023-2024 bear market.
Programming biology: next-gen AI firms raise billions to design better
Nature Biotechnology analysis of the next-generation AI biology firms that are raising billions of dollars to design better drugs and proteins, including deep dives into the approaches being used and the scientific questions they aim to answer.
Eli Lilly Invests in Startup Abridge for Clinical Trial Recruitment
Eli Lilly has made a strategic investment in Abridge, the AI medical scribe company, to accelerate clinical trial recruitment and reduce site burden, deepening the pharma's footprint in generative AI healthcare tools.
Where Does Biopharma Go From Here?
Endpoints' Q2 2026 sentiment survey captures industry executives' views on capital availability, R&D productivity, M&A activity, and policy outlook heading into the second half of the year.
Enliven Prices $400M Offering; Jazz Drug Zepzelca Fails Confirmatory Study
Enliven Therapeutics priced a $400 million public offering, while Jazz Pharmaceuticals and PharmaMar announced that Zepzelca failed its confirmatory Phase 3 study in small cell lung cancer, dealing a fresh blow to the partners' strategy of positioning the drug in earlier lines of therapy.
FDA Imposes Import Alert on Dabur India's Plant After Inspectors Flag GMP Failings
The FDA has imposed an import alert against Dabur India after inspectors found bird droppings, an unidentified black substance on warehouse ceilings, and data integrity deficiencies at one of the company's facilities, potentially allowing authorities to detain shipments of antibiotics, dietary supplements, and other drugs.
Beyond Sunshine: Iberia's Biotech Moment Has Arrived With Developing Capital Networks
Spain and Portugal are emerging as a credible European biotech hub beyond the traditional Catalonia/Madrid axis, with growing capital networks and a new wave of funding vehicles starting to compete with Paris and London for biotech creation.
Merck, Gilead Serve 'Sweet and Sour' Spread After HIV Win, Cancer Stumble
Merck and Gilead posted mixed data at a major oncology-HIV conference, with Merck's HIV program delivering a positive pivotal readout while Gilead's Trodelvy missed again in lung cancer, dragging on the company's oncology narrative.
Novartis Dystrophy Data Tee Up Regulatory Talks on Avidity Drug
Novartis executives said the company's muscular dystrophy data—built around the $12B Avidity Biosciences acquisition—pave the way for near-term regulatory submissions in DM1 and DMD.
Novo Nordisk Hit With Cybersecurity Breach, Urges Vigilance Among Trial Participants
Novo Nordisk disclosed a cybersecurity breach affecting clinical trial participant data, urging patients to remain vigilant. The incident follows a broader pattern of cyberattacks targeting pharma and adds to Novo's 2026 challenges.
The Oral GLP-1 Tracker: Novo's Wegovy Pill Keeps Gaining Ground
Fierce Pharma's quarterly oral GLP-1 launch tracker shows Novo Nordisk's Wegovy pill continuing to capture scripts at a faster rate than Eli Lilly's Foundayo in early launch markets, with both drugs now expanding into new indications.
WuXi AppTec Sues Pentagon in Challenge Over Inclusion on Chinese Military List
WuXi AppTec has filed suit against the U.S. Department of Defense, challenging its inclusion on the Chinese military companies list. The lawsuit escalates a multi-year dispute that has shaped the biotech supply chain and raised concerns from pharma clients about outsourcing to Chinese CDMOs.
Zepzelca Saga Takes Another Turn With Ph. 3 Lung Cancer Flop
Jazz Pharmaceuticals and partner PharmaMar's Zepzelca (lurbinectedin) has failed a confirmatory Phase 3 study in small cell lung cancer, raising fresh questions about the drug's accelerated approval and Jazz's oncology strategy.
Abridge wants to be the operating system for medicine—and NVIDIA and Eli Lilly are helping build it
Abridge announced strategic partnerships with Eli Lilly (a strategic investment) and NVIDIA (a co-developed foundation model for clinical conversations) as the AI documentation company expands beyond documentation into a broader clinical operating platform.
Astellas Outlines CEO's 5-Year Plan to Counter the Xtandi Patent Cliff
Astellas CEO Naoki Okamura detailed a five-year strategic plan centered on the company's post-Xtandi oncology and women's health franchises, projecting a path back to growth as the prostate cancer blockbuster faces generic competition later this decade.
The Wait Continues: Pressure to Operate Lean Among Factors Behind Slow Biopharma Job Market
Just 23% of respondents to a BioSpace LinkedIn poll expect the biopharma job market to rebound in 2026. Three experts discuss when they see a turnaround happening and how increasing emphasis on cost efficiency is impacting hiring practices across the industry.
Biopharma pay report: Top-paid CSOs, CMOs of 2025
Biopharma pay report: Top-paid CSOs, CMOs of 2025.
Here Are Biopharma's 10 Highest-Paid Scientists and Doctors for 2025
Endpoints' annual ranking of the 10 highest-paid biopharma scientists and doctors in 2025, with a methodology note on how cash, equity, and performance-share structures shifted versus 2024.
Nonprofit Blood Cancer United Buys Experimental Cancer Drug Luvelta to Maintain Patient Access
The nonprofit Blood Cancer United has acquired the experimental cancer drug Luvelta to ensure continued access for patients enrolled in ongoing trials after the developer signaled it would wind down the program, an unusual arrangement that highlights the financial pressure on small-molecule oncology development.
Camurus' Second CRL for Acromegaly Drug; Teva Details Workforce Cuts
Camurus received a second Complete Response Letter from FDA for its acromegaly candidate, while Teva provided fresh details on its multi-year workforce reduction plan covering both its generics and specialty operations.
Charles River CEO Says It Likely Won't Be the Last Manufacturer to Break Away From Cell and Gene Therapy
Charles River Laboratories' CEO said the company's recent decision to wind down its cell and gene therapy CDMO business is likely a leading indicator of broader industry rationalization, as capital costs and clinical failure rates reshape the manufacturing landscape.
Drugmakers Turn to Logistics Providers as Trade Disruptions Linger, DHL Exec Says
Pharmaceutical manufacturers are increasingly relying on third-party logistics providers to manage supply chain complexity as US-China trade tensions and tariff uncertainty persist, according to a senior DHL executive.
Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components
Enliven Therapeutics announced updated positive Phase 1 clinical data for its menin inhibitor in acute myeloid leukemia, with alignment with FDA on key Phase 3 trial design components. The drug targets a specific subtype of AML with high unmet need.
Germany's Health-Spending Plan Has Consequences as Lilly, Boehringer Scale Back
Eli Lilly and Boehringer Ingelheim are scaling back German operations in response to the country's proposed health-spending cuts, raising questions about Europe's largest pharma market's ability to attract R&D investment.
Kardigan Stitches Up $369M IPO Plan for Heart Drugs
Kardigan, the cardiology biotech led by a former MyoKardia executive, has filed to raise up to $369M in a US IPO to fund a pipeline of three in-licensed cardiovascular programs targeting cardiomyopathies and related heart conditions.
Madrigal Takes Giant Inflatable Liver on US Tour for Disease Awareness
Madrigal Pharmaceuticals is touring the United States with a giant inflatable liver to raise awareness of MASH (metabolic dysfunction-associated steatohepatitis) and its approved therapy Rezdiffra, the first FDA-approved drug for the disease.
May 2026 Biopharma Layoffs Hit Nearly 7,000, With Most Cuts From Takeda and BioNTech
For the second time in 2026, the number of biopharma professionals affected by made or projected workforce reductions rose year over year. In May, layoffs spiked nearly 50% to 6,956 employees, mainly due to Takeda and BioNTech axing a combined 6,360 employees.
Neion Bio Raises Oversubscribed $23 Million Series A to Advance Biologics Manufacturing Platform and Expand Pipeline
Neion Bio Raises Oversubscribed $23 Million Series A to Advance Biologics Manufacturing Platform and Expand Pipeline.
Neion Bio Raises Oversubscribed $23 Million Series A to Advance Biologics Manufacturing Platform and Expand Pipeline
Neion Bio Raises Oversubscribed $23 Million Series A to Advance Biologics Manufacturing Platform and Expand Pipeline.
Portugal, Spain, and the New Biotech Frontier
Iberia's biotech sector is emerging as a serious third hub behind the U.K. and Germany, with deep academic science, growing late-stage capital, and a new wave of cross-border partnerships.
Sky-High Parabilis, Kailera IPOs Spur Optimism—But Only for Derisked Biotechs
Two biotechs—Parabilis Medicines and Kailera—have set industry records with back-to-back IPOs, but experts caution that only derisked pipelines with validated mechanisms are reaping rewards while broader biotech sentiment remains cautious.
Takeda's AI-Designed Pill Bests BMS' Sotyktu in Head-to-Head Psoriasis Trial
Takeda's oral allosteric TYK2 inhibitor, designed with the help of generative AI, beat Bristol-Myers Squibb's Sotyktu in a head-to-head Phase 3 trial in moderate-to-severe plaque psoriasis, positioning it as a potential best-in-class oral therapy.
New Biotech Group Rises to Fuel American Rockets in China 'Space Race'
The American Biotech Innovation Alliance (ABIA) launched with the goal of building a national biotech strategy for the United States, modeled on China's coordinated approach to the sector, to maintain American competitiveness in life sciences innovation.
Eli Lilly's 340B Claims Data Deadline May Kick Off a New 340B Fight
Eli Lilly is moving forward with a hospital claims data submission deadline tied to its 340B drug pricing program, a step that could trigger a new round of disputes with safety-net hospitals and reshape how the contract pharmacy channel operates.
Ethyreal Lands $101M to Treat Both Graves' and Thyroid Eye Disease
Ethyreal Therapeutics closed a $101M financing to advance a dual-acting antibody aimed at both Graves' disease and thyroid eye disease, two autoimmune indications with overlapping biology but few targeted therapies.
FDA Details Flexibilities for New Cell and Gene Therapies to Leverage Past Data
The FDA has released new guidance clarifying how sponsors of cell and gene therapies can leverage prior clinical and CMC data from related programs to accelerate development timelines, in a move likely to speed the next wave of regenerative medicine approvals.
Explaining Unapproved Drugs to Payors: FDA Offers Pharma New Guidance to Avoid Pitfalls
The FDA has issued new draft guidance for pharmaceutical companies on how to communicate with payors about unapproved drugs and investigational uses, aiming to reduce off-label misinformation and clarify permissible pre-approval communication.
Local Trade Groups Must Support Life Sciences in These Difficult Times
An opinion column arguing that as the industry faces policy changes and significant cuts to federal funding, local life sciences trade groups can bolster companies through innovative resources to sustain growth and keep the US at the center of biomedical innovation.
Parabilis' $670M IPO Sets New Biotech Record, Will Fund Cancer Drug
Parabilis Medicines raised $670 million in an industry-record IPO, the largest biotech public offering to date, with proceeds earmarked to advance its lead cancer program into the clinic.
Shattuck Raises $75M; Servier Inks Neuro ASO Pact with n-Lorem Foundation
Shattuck Labs closed a $75M financing round, while Servier announced a partnership with the n-Lorem Foundation to develop antisense oligonucleotide (ASO) therapies for ultra-rare neurological diseases.
Big Pharma-Backed SonoThera Sounds Off With $125M Series B for Ultrasound-Based Gene Therapy
SonoThera, a biotech developing ultrasound-based, non-viral gene therapies, raised a $125 million Series B led by multiple Big Pharma partners. The funding will advance its lead programs in genetic medicine toward clinical trials.
City Therapeutics Gets $99M to Gather Data on Three RNAi Medicines
City Therapeutics has closed a $99M financing round to advance its pipeline of three RNAi medicines, betting on a next-generation small interfering RNA platform that aims to improve potency and durability over current standards.
USP Annual Drug Shortages Report finds rising discontinuations, hidden upstream risk
The U.S. Pharmacopeia's annual drug shortages report finds rising discontinuations and hidden upstream supply-chain risk, with drug shortages remaining a systemic problem in the U.S. and affecting multiple therapeutic areas.
Trodelvy Misses Again in Lung Cancer, but Gilead and Merck Have an HIV Success to Soften the Blow
Gilead's Trodelvy failed a second late-stage lung cancer trial, further narrowing the ADC's commercial prospects outside of triple-negative breast cancer. Gilead and Merck separately reported positive HIV data, providing partial offset to the disappointing oncology readout.
ADA: Kailera 'Back at Work' After Record-Breaking IPO With China Data in Hand
Kailera Therapeutics executives said the obesity biotech is back to building pipeline after a record-breaking IPO, presenting Phase 2 data from China on its lead GLP-1/GIP candidate at the American Diabetes Association conference.
Japan pharmaceutical firm warns against rare diseases drug after 20 deaths
Japan pharmaceutical firm warns against rare diseases drug after 20 deaths.
Cavalry Biosciences Pursues $75M Series B to Test Eye and Muscle Disorder Drugs
Cavalry Biosciences is raising a $75 million Series B to advance its pipeline of oligonucleotide therapies for inherited eye and muscle disorders, joining a small group of well-capitalized genetic medicine startups building on the success of the modality in neuromuscular disease.
Sanofi, OpenAI, and Formation Bio Partner to Accelerate Drug Development
A first-of-its-kind collaboration to build AI-powered software and custom applications, aiming to bring new medicines to patients more efficiently by leveraging OpenAI's technology and Formation Bio's clinical platform.
Rethinking Hair Loss Treatment: New Mechanisms Move Into the Clinic
A new generation of hair-loss therapies is moving into clinical trials, targeting pathways beyond the JAK-IGF-1 axis that have dominated the field since the approval of JAK inhibitors for alopecia areata.
BrainStorm levels up, bringing on former FDA leader Peter Pitts for new ALS bid
For Peter Pitts, a former associate commissioner at the FDA, the appointment to the board of BrainStorm Cell Therapeutics is an opportunity to fulfill a promise he made long ago to a patient with ALS.
FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients
The FDA issued draft guidance aimed at accelerating the development and review of cell and gene therapies, with a focus on rare-disease and unmet-medical-need applications.
Insilico Medicine Announces Nature Medicine Publication of Phase IIa Results Evaluating Rentosertib for IPF
Insilico Medicine announced publication of Phase IIa results in Nature Medicine for rentosertib (INS018_055), the novel TNIK inhibitor for idiopathic pulmonary fibrosis (IPF). The drug was discovered and designed with the company's pioneering AI approach. Phase 2 trials are ongoing.
Curse of the straight-A student
The people most trusted to deliver are not always the ones invited to shape direction. Executive coach Angela Justice examines why the habits that build a career can eventually limit advancement.
The Biotech Hiring Market in 2026: Where Things Actually Stand
An analysis of the biotech hiring market in 2026 shows that bioinformatics and computational biology skills remain among the hardest-to-fill categories, with capital flowing into the sector faster than the talent infrastructure can support it. Demand for hybrid wet-lab plus data-science skills continues to outpace supply.
AHA urges HRSA to stop Novo Nordisk's new claims-data submission policy for 340B
On January 26, the AHA urged HRSA to take immediate action to stop Eli Lilly from requiring 340B covered entities to submit claims data for all dispensations of all Lilly drugs.
Showing 1-12 of 963 articles
AI-Native Biopharma
Therapeutics developers leveraging computational biology and AI foundation models as core pipelines.
Abiologics
PrivateProfile of Abiologics created from news harvest. To be enriched by user.
HQ:Cambridge
Funding:N/A
Key Pipeline Asset:
Services: Drug target and therapeutic discovery company using single-cell genomics and bioinformatics to provide biomarker identification and drug target services for pharmaceutical partners. | Leadership: Not found on website | Keywords: single-cell genomics, bioinformatics, drug discovery, omics, therapeutics
HQ:United States
Funding:N/A
Abridge
PrivateAbridge is a privately held healthcare AI company that builds ambient-AI clinical documentation and conversation-summarization tools used by physicians, nurses, and health systems. The platform listens to patient-clinician encounters and automatically generates structured clinical notes, billing codes, and patient summaries. In June 2026, Abridge announced parallel strategic partnerships with Nvidia (for compute infrastructure) and Eli Lilly (to deploy its platform in Lilly-sponsored clinical trial recruitment and consent workflows).
HQ:San Francisco
Funding:>$700M cumulative venture-backed funding through 2026
Key Pipeline Asset:
Biopharmaceutical company. AI / Machine Learning
HQ:United States
Funding:N/A
Aidoc Medical
PrivateAidoc Medical is an AI medical imaging company whose CARE platform uses deep learning to triage and detect acute abnormalities in CT scans, with FDA-cleared applications including the CARE Body CT Multi-Triage.
HQ:New York
Funding:N/A
Alto Neuroscience
NYSE: ANROAlto Neuroscience is a clinical-stage biopharmaceutical company developing precision psychiatry medicines using biomarker-driven patient stratification to treat depression and other central nervous system disorders.
HQ:Mountain View
Funding:N/A
Key Pipeline Asset:
Autonomous Healthcare
PrivateAutonomous Healthcare is a medical device company developing AI-driven ventilator waveform analysis software. Their Syncron-E platform received FDA De Novo marketing authorization in July 2026, creating a new FDA device category for ventilator data software.
HQ:Newark
Funding:Disclosed via press releases
Key Pipeline Asset:
Avenda Health
PrivateAvenda Health is a ai-enabled medical devices company. See today's news for the latest developments.
HQ:Los Angeles
Funding:$50M+
Key Pipeline Asset:
Basecamp Research
PrivateBasecamp Research is a London-based AI biotechnology company that trains frontier models for therapeutic design on BaseData, a proprietary evolutionary genomic dataset of more than 100 billion novel genes gathered across all seven continents. Its 28-billion-parameter model, EDEN, translates that data into gene insertion, gene editing and peptide therapeutics now advancing through preclinical development.
HQ:London
Funding:~$225M
Key Pipeline Asset:
Beacon Biosignals
PrivateAI software/electroencephalography for neuro biomarker discovery
HQ:MA - Boston
Funding:N/A
AI-guided antibody design platform. Protein therapeutics company developing next-generation antibody drugs. Partnered with Eli Lilly. San Francisco Bay Area. Leadership (added 2026-06-10, source: https://www.bighatbio.com/about): Nicholas Young Scientist II (Senior Director, Antibody Engineering)
HQ:United States
Funding:N/A
BioXcel Therapeutics
OTC: BTAIQBioXcel Therapeutics (rebranding to BX Liquidation, Inc.) was a clinical-stage biopharmaceutical company that leveraged artificial-intelligence–driven drug discovery to develop neuroscience and immuno-oncology medicines. Following its August 2026 Chapter 11 bankruptcy filing, on October 30, 2026 BioXcel completed the sale of substantially all assets relating to its lead commercial product IGALMI (sublingual dexmedetomidine) to Teva Pharmaceuticals for $57.5 million cash. Concurrently, the Board terminated the employment of its entire executive leadership team (CEO Vimal Mehta, CFO Richard Steinhart, CSO Frank Yocca, and CLO Javier Rodriguez) effective October 31, 2026, transitioned management to Chief Restructuring Officer Samir Saleem as President and Secretary, and authorized changing the company name to BX Liquidation, Inc. to formally wind down and liquidate remaining corporate affairs.
HQ:New Haven
Funding:N/A
Key Pipeline Asset:
Black Arrow Biotech
PrivatePeptide Libraries for AI Cancer Drug Discovery
HQ:Estonia - Tallinn
Funding:N/A
Brainomix
PrivateOxford University spinout developing AI-powered imaging biomarkers for stroke, lung cancer and pulmonary fibrosis. FDA cleared.
HQ:Oxford
Funding:N/A
Key Pipeline Asset:
Cadence
PrivateProfile of Cadence created from news harvest. To be enriched by user.
HQ:United States
Funding:N/A
Key Pipeline Asset:
Precision cardiovascular medicine company offering AI-driven genetic-epigenetic technology for heart attack risk assessment and disease prevention. Public company (NASDAQ: CDIO).
HQ:United States
Funding:N/A
Denali Therapeutics
NASDAQ: DNLIDenali Therapeutics (NASDAQ: DNLI) is a biotechnology company headquartered in South San Francisco, California, developing a broad portfolio of therapeutics for neurodegenerative diseases through its proprietary blood-brain barrier (BBB) delivery platform (the ATV/Otv platform, including Enzyme Transport Vehicle and Oligonucleotide Transport Vehicle technologies). Denali's clinical and preclinical pipeline targets Parkinson's disease (BIIB122/DNL151, partnered with Biogen), Hunter syndrome (DNL310, tividenofusp alfa), ALS (DNL343), and multiple other lysosomal storage diseases and neurodegenerative indications. The company was founded in 2015 by a team that included former Genentech scientists.
HQ:South San Francisco
Funding:N/A
Dogwood Therapeutics
NASDAQ: DWTXDogwood Therapeutics (formerly Virios Therapeutics, renamed October 2024) is a development-stage biotechnology company focused on first-in-class, non-opioid medicines for pain and fatigue-related disorders. Its lead candidate, Halneuron, is a highly selective sodium channel blocker in Phase 2b development for chemotherapy-induced neuropathic pain (CINP) and cancer pain, with a 12-week open-label follow-on study commenced in May 2026; IMC-1 (famciclovir + celecoxib) completed a Phase 2b trial in fibromyalgia. Founded in 2012 and headquartered in Alpharetta, Georgia.
HQ:Alpharetta
Funding:N/A
Key Pipeline Asset:
Enlil
PrivateGoverned AI foundation platform for medical device manufacturers, enabling regulatory-compliant AI integration in healthcare.
HQ:United States
Funding:N/A
Ensysce Biosciences
NASDAQ: ENSCEnsysce Biosciences (NASDAQ: ENSC) is a clinical-stage pharmaceutical company based in La Jolla, California, developing next-generation prescription drugs for severe pain with built-in abuse and overdose protection. Its Trypsin Activated Abuse Protection (TAAP) platform is designed to release clinically effective drugs only under specific physiological conditions, and its Multi-Pill Abuse Resistance (MPAR) platform is an overdose-protection opioid prodrug technology. The lead candidate is PF614, a TAAP oxycodone prodrug in a pivotal Phase 3 trial (PF614-301) for moderate-to-severe acute pain, alongside PF614-MPAR, which holds FDA Breakthrough Therapy designation. The company is also developing amphetamine prodrugs for ADHD (PF8001, PF8026) and PF9001 for opioid use disorder, and launched a formal review of strategic alternatives in May 2026.
HQ:La Jolla
Funding:N/A
Key Pipeline Asset:
Enveda Biosciences
PrivateEnveda is an AI-driven drug discovery company that reads nature's untapped chemistry through metabolomics and machine learning to discover small-molecule medicines roughly four times faster than the industry average. Its pipeline spans obesity and metabolic disease, immunology and inflammation, fibrosis and neurosensory disorders, and the company has raised more than $845 million since 2019.
HQ:Boulder
Funding:~$845M
Key Pipeline Asset:
Evaxion
NASDAQ: EVAXEvaxion is a clinical-stage biotechnology company developing AI-driven immunotherapies, including personalized cancer vaccines and vaccines targeting bacterial pathogens, using its proprietary AI platforms PIONEER and EDEN.
HQ:Copenhagen
Funding:N/A
Formation Bio
PrivateFormation Bio is an AI-native drug development company building a clinical-stage pipeline through in-licensing and asset acquisition, with a focus on using technology and AI to accelerate clinical trial execution. In early 2026, the company launched a new subsidiary, Kenmare Bio, to develop a miR-124 inhibitor licensed from a Chinese partner for inflammatory diseases.
HQ:New York
Funding:$600M+
Key Pipeline Asset:
Generate Biomedicines
NASDAQ: GENBGenerate Biomedicines, Inc. (NASDAQ: GENB) is a clinical-stage generative-biology company headquartered in Somerville, Massachusetts, using machine learning and its Generate Platform to program novel protein therapeutics; it went public in February 2026 and is a Flagship Pioneering-founded company whose lead programs span immunology (GB-0895 anti-TSLP) and oncology (GB-4362, GB-5267).
HQ:Somerville
Funding:N/A
Key Pipeline Asset:
Ginkgo Bioworks Holdings
NYSE: DNAGinkgo Bioworks is a cell-engineering and synthetic-biology platform company that programs cells and builds the data, software and automation infrastructure around them. Its Ginkgo Datapoints offering generates biology-scale datasets — functional genomics, antibody developability and small-molecule developability — formatted for machine-learning consumption, and supplies them into third-party AI drug-discovery networks. The company runs large-scale autonomous laboratory infrastructure, including a cloud-accessible lab interface, and sells cell-engineering research and development services across pharmaceutical, biotechnology, agriculture, industrial, food and nutrition, and government customers. Ginkgo completed the divestiture of its biosecurity segment in 2026 and has concentrated its investment on autonomous labs, AI-ready biological data and cost-competitive contract research services.
HQ:Boston
Funding:N/A
HeartSciences
NASDAQ: HSCSHeartSciences is a medical technology company advancing electrocardiography (ECG) through the integration of artificial intelligence. Its MyoVista Insights platform is a cloud-native, vendor- and device-agnostic ECG management system, while the MyoVista wavECG device delivers conventional resting 12-lead ECG functionality with on-device AI-enabled algorithms; the company has submitted the wavECG device to the FDA for 510(k) clearance. Incorporated in 2007 as Heart Test Laboratories and renamed HeartSciences in October 2024, the Southlake, Texas-based company listed on Nasdaq in June 2022. In June 2026 it announced a definitive all-stock business combination with Fortitude Mining Holdings, a vertically-integrated Zcash mining platform, under which existing HeartSciences holders would retain roughly 5% of the combined company.
HQ:Southlake
Funding:N/A
Key Pipeline Asset:
Iambic Therapeutics
PrivateAI-driven small molecule drug discovery company whose Enchant platform combines generative models such as NeuralPLexer with high-throughput experimentation to design therapeutics; partnered with AbbVie and Revolution Medicines.
HQ:San Diego
Funding:~$150M
Key Pipeline Asset:
ICON plc
NASDAQ: ICLRICON plc is one of the world's largest clinical research organizations (CROs), providing outsourced drug development services to pharmaceutical, biotechnology, and medical device companies. ICON announced a strategic technology partnership with Microsoft in 2026 to accelerate AI-driven clinical trial design and execution.
HQ:Dublin
Funding:N/A
Insilico Medicine
PrivateInsilico Medicine is an end-to-end generative artificial intelligence-driven drug discovery company connecting biology, chemistry, and clinical trials analysis.
HQ:Boston
Funding:$415M
Key Pipeline Asset:
insitro
PrivateMachine-learning-driven drug discovery company that builds predictive models of human disease from large-scale cellular data and patient genetics, then advances the resulting insights into small-molecule and antibody therapeutics.
HQ:South San Francisco
Funding:~$700M
Key Pipeline Asset:
Invenio Imaging
PrivateMedtech company developing NIO Laser Imaging System, using stimulated Raman histology for intraoperative fresh tissue imaging, plus AI-based image analysis for cancer detection.
HQ:Santa Clara
Funding:N/A
LifeMine Therapeutics
PrivateClinical-stage biopharmaceutical company pioneering Top-Down Drug Discovery, which leverages evolutionary insights from fungi to develop next-generation precision medicines. In August 2026 it raised a combined $263 million (Series D + Series F) to support the clinical program for LIFE-001, under development to prevent organ failure.
HQ:Cambridge
Funding:$263M (2026)
Key Pipeline Asset:
Services: AI superintelligence for autonomous lab-based experimentation compressing R&D cycles from decades to months. Science superintelligence platform for drug discovery and materials science. | Leadership: Geoffrey von Maltzahn (Co-Founder & CEO, Flagship Pioneering), Chief Scientist (TBD) | Keywords: AI drug discovery, autonomous labs, scientific superintelligence, robotics, machine learning
HQ:United States
Funding:N/A
Lunai Bioworks
NASDAQ: LNAILunai Bioworks (NASDAQ: LNAI), formerly Renovaro Inc. (renamed August 2025), is an AI-driven precision medicine and biodefense company headquartered in Los Angeles. The company operates through three segments — RENB (cell therapy vaccines), BioSymetrics (AI drug discovery), and RENC (CNS) — developing genetically modified allogeneic dendritic cell therapeutic vaccines including RENB-DC11 for solid tumors (primarily pancreatic) and RENB-DC20 for breast cancer, plus an AI multi-omics platform for early cancer detection and recurrence monitoring. In May 2026 Lunai completed a $20M preferred issuance to acquire CNS delivery and neurotherapeutic IP, and in July 2026 it launched a foundation-funded Parkinson's and rare epilepsy AI discovery collaboration with BrainStorm Therapeutics. The company is also pursuing federal biodefense contracts. Since May 2026 it has pursued a naked-short-selling fraud suit under Regulation SHO and RICO, filing a First Amended Complaint on August 4, 2026 naming ten defendants including three FINRA-registered broker-dealers.
HQ:Los Angeles
Funding:N/A
Key Pipeline Asset:
Pacira BioSciences
NASDAQ: PCRXPacira BioSciences is a specialty pharmaceutical company focused on the development, manufacture and commercialization of non-opioid pain management and regenerative health solutions. Its commercial portfolio includes EXPAREL (bupivacaine liposome injectable suspension) for postsurgical pain, ZILRETTA (triamcinolone acetonide extended-release injectable suspension) for osteoarthritis knee pain, and the iovera system, a handheld cryoanalgesia device. On October 8, 2026, Viatris agreed to acquire Pacira for $36.50 per share in cash in a transaction valued at approximately $1.65 billion.
HQ:Brisbane
Funding:N/A
Key Pipeline Asset:
Pathos AI
PrivateAI-enabled precision oncology biotech that uses multimodal patient data, biological modeling, and machine learning to identify Phase 1 cancer drugs for specific patient subgroups, partnering with pharma for clinical trial design and drug repositioning.
HQ:Chicago
Funding:$62M
Perimeter Medical Imaging AI is a commercial-stage medical imaging company developing AI-driven optical coherence tomography (OCT) for breast cancer surgery and other surgical oncology applications.
HQ:Toronto
Funding:N/A
Potential Sciences
PrivatePotential Sciences is an AI and computational chemistry startup based in Cambridge and London, backed by the UK Government's Sovereign AI Fund. The company builds atomistic foundation models and re-engineers gold-standard quantum chemistry algorithms like CCSD(T) to run natively on modern GPU clusters, enabling physics-driven molecular property prediction and de novo drug discovery at orders of magnitude lower compute cost.
HQ:Cambridge and London
Funding:£15M+
Pythia Labs
PrivatePythia Labs is a generative AI biotechnology company pioneering all-atom foundation models for the de novo computational design of full-length therapeutic antibodies and functional biologics. Its flagship architecture, Pythia-1, designs agonist and antagonist antibodies directly from atomic target specifications across multi-pass membrane proteins and GPCRs.
HQ:San Francisco
Funding:N/A
Real Chemistry
PrivateReal Chemistry is a healthcare marketing and technology company that builds AI tools and data products for life sciences clients. Their Anatomi platform is part of a growing body of AI-driven healthcare marketing and analytics products.
HQ:San Francisco
Funding:See company disclosures
Key Pipeline Asset:
Services: AI-driven preclinical cancer drug development; organoid-based drug discovery; FDA Fast Track designation | Leadership: — | Keywords: AI, organoids, cancer, targeted therapy, gastric cancer
HQ:United States
Funding:N/A
Silexion Therapeutics
NASDAQ: SLXNSilexion Therapeutics is a clinical-stage biopharmaceutical company developing RNA interference (RNAi)-based cancer therapies and delivery systems for malignant solid tumors, built on its proprietary LODER delivery platform. Lead programs include SIL204, an RNAi therapeutic targeting KRAS-driven cancers now in clinical development, and SiG12D-LODER, which completed an open-label Phase 1 trial in pancreatic cancer; Prostate-LODER and GBM-LODER are in preclinical development. The company collaborates with Evonik on advanced siRNA formulation and is headquartered in Jerusalem, Israel, with a Nasdaq listing since 2025.
HQ:Jerusalem
Funding:N/A
Key Pipeline Asset:
SimBioSys
PrivateSimBioSys is a digital health company applying AI to tumor biology to enable precision oncology. Its platform integrates multi-modal patient data to model tumor behavior and predict response to therapy. Partners with Ferrum Health (2026) to expand AI-powered surgical planning access.
HQ:Chicago
Funding:N/A
Slate Medicines
PrivateSlate Medicines is a clinical-stage biotechnology company developing anti-PACAP therapeutics for migraine and headache disorders. The company launched in 2026 with a $130M Series A to advance its lead program SLTE-1009 and other PACAP-pathway candidates, joining a competitive class of next-generation migraine developers seeking to challenge the CGRP inhibitor standard of care.
HQ:Raleigh
Funding:$130M
Key Pipeline Asset:
Tempus AI
NASDAQ: TEMTempus AI is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. Its platform collects and analyzes clinical and molecular data to enable physicians and researchers to make data-driven decisions in oncology, cardiology, and other disease areas.
HQ:Chicago
Funding:N/A
Key Pipeline Asset:
UpDoc
PrivateEnterprise-ready clinical AI company pioneering autonomous clinical AI for continuous patient care between scheduled visits. Selected by ARPA-H to lead the ADVOCATE program for AI-driven cardiovascular care management.
HQ:Stanford
Funding:N/A
Key Pipeline Asset:
Verge Labs
PrivateVerge Labs (formerly Verge Genomics) is a frontier AI lab for human disease biology founded in 2015. The company develops world models of patient biology built on proprietary multi-modal human tissue data and partners with drug developers on target discovery, patient stratification, and biomarker prediction across CNS and beyond.
HQ:San Francisco
Funding:$130M+ to date
Key Pipeline Asset:
Xaira Therapeutics
PrivateAI-driven drug discovery company applying generative models and machine learning to small molecule and biologics design.
HQ:South San Francisco
Funding:$1B+ (initial funding)
Key Pipeline Asset:
AI Infrastructure & Software
Software platforms, digital notebooks, and LIMS offering GxP-compliant AI-powered co-pilots and analytics.
10x Genomics
Hardware10x Genomics is a life sciences technology company building instruments, consumables, and software for single-cell sequencing and spatial transcriptomics. Its platforms include Chromium (single-cell RNA-seq, ATAC-seq, multiome), Visium (spatial gene expression), and Xenium (in-situ RNA imaging). LIMS integrations are available through the Loupe Browser and Connect software.
Key Tool:
Chromium X SeriesSingle-cell partitioning and barcoding platform for gene expression, immune profiling, ATAC-seq, and multiome (RNA + ATAC) assays.
Accruent
SoftwareAccruent is an enterprise asset management and CMMS provider for healthcare and life sciences, with strong adoption in hospital systems and pharma facilities. Now part of Fortive (parent of Fluke, eMaint, Gatan, etc.), Accruent provides the TMS (Trakker Maintenance System) and the Connectiv healthcare technology management platform.
Key Tool:
Accruent TMS (Trakker Maintenance System)Enterprise CMMS / EAM for healthcare and life sciences facilities, with strong regulatory compliance and audit trails.
Arena Solutions (PTC)
SoftwareArena Solutions is a cloud QMS and PLM platform acquired by PTC in 2021. Strong in medical device, life sciences, and high-tech hardware companies needing integrated product lifecycle and quality management. Built on Salesforce.
Key Tool:
Arena Quality Management System (QMS)Cloud QMS for design controls, CAPA, document control, training, and supplier quality.
Aspen Technology
SoftwareAspen Technology (AspenTech) is a leading provider of asset optimization software for industrial process manufacturers, including pharmaceuticals, chemicals, and energy. The 2024 acquisition of Open Systems International (OSI) brought the OSIsoft PI System under AspenTech's umbrella — the de facto industrial time-series historian used in pharma continuous manufacturing, plus power, water, metals, and other process industries.
Key Tool:
Aspen Technology OSIsoft PI SystemIndustrial time-series data historian — captures, stores, and visualizes sensor and process data from manufacturing equipment.
Blue Mountain
SoftwareBlue Mountain Quality Resources provides calibration and maintenance management software (EAM) designed specifically for the life sciences industry, enabling paperless calibration, asset management, and GMP compliance.
Key Tool:
Blue Mountain RAMRegulatory Asset Manager platform integrating asset management, calibration management, and maintenance work orders in a compliant GxP environment.
ComplianceQuest
SoftwareComplianceQuest is a native Salesforce-based QMS for life sciences and medical devices. Provides document control, training, CAPA, audits, and supplier quality on the Salesforce platform, with 21 CFR Part 11 compliance and GxP templates out of the box.
Key Tool:
CQ Quality Management (EQMS)Native Salesforce QMS for document, training, CAPA, audit, change, and supplier quality.
Dotmatics
SoftwareDotmatics is a scientific informatics platform for drug discovery, providing electronic lab notebook (ELN), laboratory information management (LIMS), and scientific data management (SDMS) in a unified cloud platform. Acquired by Siemens AG in 2024, it now anchors Siemens' Life Sciences portfolio for the digital lab.
Key Tool:
StudiesCloud-based electronic lab notebook purpose-built for chemistry, biology, and assay workflows with structured data capture.
eLabNext
SoftwareeLabNext is a modern electronic lab notebook and sample management platform popular in European biotech and academic labs. Renamed from eLabJournal/MonkeyBin in 2020, it now provides a unified ELN, LIMS, and lab automation platform with strong API extensibility and the Add-on Marketplace.
Key Tool:
eLabNext ELNCloud electronic lab notebook with sample tracking, protocol execution, and a Marketplace of add-ons for qPCR, plate readers, and imaging.
eMaint (Fluke Corporation)
SoftwareeMaint is a CMMS for life sciences facilities and equipment maintenance, with strong adoption in pharma manufacturing. Now part of Fluke Corporation (a Fortive operating company), it offers work order management, preventive maintenance, calibration management, and GxP-compliant maintenance records.
Key Tool:
eMaint CMMSCloud CMMS for work orders, preventive maintenance, asset tracking, and parts inventory with GxP-compliant audit trails.
Emerson Electric's Automation Solutions segment provides process control, measurement, and analytical instrumentation. In pharma, Emerson is one of the two dominant DCS vendors (alongside Honeywell Experion), with DeltaV and Syncade MES used in batch and continuous manufacturing plants worldwide.
Key Tool:
DeltaV DCSDistributed control system (DCS) purpose-built for batch and continuous pharma manufacturing, with native S88 batch recipes and electronic signatures.
ETQ (Hexagon)
SoftwareETQ Reliance is an enterprise eQMS with deep pharma and biotech presence, particularly in document control, CAPA, audit management, and supplier quality. Acquired by Hexagon AB in 2023 to anchor its Manufacturing Intelligence division, and now part of Hexagon's Manufacturing Intelligence business unit.
Key Tool:
ETQ Reliance Quality Management SystemEnterprise eQMS for document control, CAPA, training, audits, and supplier quality, with deep pharma workflows.
Greenlight Guru
SoftwareGreenlight Guru is an eQMS purpose-built for medical device companies with built-in design controls, DHF (Design History File), risk management, and FDA 21 CFR Part 11 / ISO 13485 compliance. Acquired by Collabware in 2024 to scale into adjacent regulated industries.
Key Tool:
Greenlight Guru QMSMedical device QMS with design controls, DHF, CAPA, complaint handling, and FDA 21 CFR Part 11 compliance.
IQVIA
MixedIQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, offering Orchestrated Customer Engagement (OCE) and clinical data platforms.
Key Tool:
Orchestrated Customer Engagement (OCE)Life sciences commercial platform integrating CRM, marketing, and analytical tools tailored for healthcare sales.
LabArchives
SoftwareLabArchives is a leading electronic lab notebook (ELN) platform widely adopted by academic institutions, pharmaceutical companies, and biotech startups. It offers a Marketplace of integrations with SnapGene, GraphPad Prism, and other lab applications, plus a free tier for individual researchers.
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LabArchives NotebookCloud-based electronic lab notebook with rich-text editing, version history, e-signatures (21 CFR Part 11), and offline sync.
MaintainX
SoftwareMaintainX is a modern mobile-first CMMS for maintenance, inspections, and work order management. Used in manufacturing and life sciences facilities for uptime tracking, with strong mobile UX for technicians and a freemium model for small teams.
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MaintainX CMMSMobile-first CMMS with work orders, preventive maintenance, asset hierarchy, and procedures with photos/videos.
MasterControl
SoftwareMasterControl Inc. is a leading provider of cloud-based quality management systems (QMS) and manufacturing execution software (MES) for life sciences and other highly regulated industries.
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MasterControl Quality ExcellenceEnterprise QMS platform covering document control, training, CAPA, and audits to ensure GxP regulatory compliance.
Mettler-Toledo International
HardwareMettler-Toledo International is a leading global manufacturer of precision instruments and services for use in laboratories and manufacturing. Its portfolio includes laboratory balances, pipettes, pH meters, density meters, refractometers, and process analytics for pharma manufacturing. The LabX software platform centralizes instrument data management.
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Mettler Toledo XPR Analytical BalancesHigh-precision analytical and microbalances with integrated StatusLight, ProFACT advanced internal adjustment, and RFID-enabled SmartGrid weighing pans.
Qualio
SoftwareQualio is a cloud-based Quality Management System (QMS) built specifically for life sciences start-ups and growing companies in medical devices, pharmaceutical, and biotech sectors.
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Qualio QMSAn intuitive, cloud-native QMS built to automate document control, training logs, CAPA, and supplier management.
Sapio Sciences
SoftwareSapio Sciences is a modern cloud-based LIMS+ELN platform with a configurable scientific data model. Strong adoption in clinical genomics, cell therapy, antibody discovery, and pharma R&D, where labs need flexibility to model complex molecule-centric workflows.
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Sapio LIMSCloud LIMS with no-code workflow builder, sample tracking, and chain-of-custody for regulated labs.
SciNote
SoftwareSciNote is a modern electronic lab notebook with a free tier for individual labs and team plans for biotech, with strong integrations for molecular biology (SnapGene), statistics (GraphPad), and electronic signatures. Particularly strong in academic and small-biotech settings.
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SciNote ELNCloud electronic lab notebook with 21 CFR Part 11-ready electronic signatures, integrations, and offline mode.
Scispot
SoftwareScispot is a modern LIMS and ELN platform purpose-built for biotech and synthetic biology labs. Includes inventory, sample tracking, and AI-driven notebook features, with strong out-of-the-box support for plasmid design, cell line tracking, and bioprocess workflows.
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Scispot LIMS+Cloud LIMS with built-in plasmid/sequence registries, inventory, and bioprocess tracking — no code required.
Seal
SoftwareSeal (formerly Opvia) provides a modern, all-in-one GxP workspace for biotechnology and manufacturing teams, integrating quality management (QMS), electronic lab notebooks (ELN), and lab information systems (LIMS) with AI-powered co-pilots.
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Seal GxP PlatformA consolidated cloud platform designed to replace fragmented MES, LIMS, QMS, and ELN systems, featuring version-controlled blueprints and AI co-pilots.
Veeva Systems
SoftwareVeeva Systems Inc. is a leading provider of cloud-based software solutions for the global life sciences industry, specializing in clinical trial management, regulatory compliance, and customer relationship management.
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Veeva Vault ClinicalUnified suite of cloud applications designed to streamline clinical trial operations, data management, and documentation.
ZenQMS
SoftwareZenQMS is a modern cloud eQMS for life sciences with strong focus on GMP document control, training, and change management. Popular in mid-market pharma/biotech for its clean UX and quick implementation.
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ZenQMS eQMSCloud eQMS for document control, training, change control, deviations, and CAPA with GxP templates.