Aggregating recent news and profiling companies at the frontier of computational biology, generative molecular design, and AI-native clinical development.
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 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 said its experimental treatment barzolvolimab hit its primary endpoint in two Phase 3 trials, even as the readout raised safety concerns.
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.
One of Roivant's leading autoimmune pipeline candidates failed a Phase 2b study in a form of lupus, the company said Wednesday morning.
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 Inc., a Korean medical technology company specializing in AI-powered emergency care, announced the global expansion of A-LRYNGO™, the...
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.
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.
Kedrion Biopharma announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Immune globulin...
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.…
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.
Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
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.
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 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.
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.
At its capital markets day Novo unveiled pipeline-diversification and bolt-on deal plans, but shares slid 5% as investors wanted bigger swings.
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 Biosciences' cannabinoid agonist held its own against GLP-1 drugs in obese mice, per a preclinical study.
An explainer on 'Asian glow' - the alcohol-flushing response linked to the ALDH2 variant - and why clinicians should counsel patients on drinking risks.
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
RIVANNA has secured a new CMS procedure code covering computer-aided neuraxial guidance.
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.
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
Centric Compounding recalls six lots of Glutathione, Myers' Cocktail and Tri-Immune Boost injections over endotoxin contamination after nine adverse event reports.
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
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.
News from Fierce Biotech: Novartis pays Sironax $125M to acquire brain delivery platform
The Swiss pharma giant is ending work on VHB937/lifonebart in ALS, according to a letter from the company's clinical development team.
Anthropic partners with Novo to tackle drug discovery using Claude Science AI. Financial terms undisclosed. Novo also has a similar deal with OpenAI.
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 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.
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.
News from PR Newswire: Applied Photonix Launches ViroZap, the First FDA-Cleared Medical Device for In-Duct Air Disinfection
News from BioPharma Dive: AstraZeneca's newly approved pill fails frontline breast cancer study
News from Endpoints News: Axoltis says its Phase 2 study for an experimental ALS drug failed
News from Fierce Biotech: Connect not dismayed by Dupixent rival's ph. 2 asthma failure
News from Endpoints News: Contineum, J&J's drug fails in mid-stage depression trial
News from BioSpace: Despite 3 patient deaths, Cullinan-Taiho plan FDA filing for lung cancer pill on survival benefit
News from Pharmaphorum: Electra sets terms for IPO, hoping to raise up to $347m
News from Endpoints News: Exclusive: Kairon Health raises $5M to use data to make patients healthier
News from BioSpace: AAM sounds alarm on unsustainable race to the bottom for generics and biosimilars
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 next-generation SERD has disappointed in a Phase 3 trial for untreated advanced breast cancer.
News from BioSpace: AstraZeneca's newly approved cancer pill fails late-stage study, blocking path to bigger market
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 reports strong overall survival data for its PD-1xVEGF bispecific antibody ivonescimab, demonstrating superiority over Keytruda in PD-L1-high NSCLC.
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.
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 Bioscience secures additional funding; AbbVie's Qulipta succeeds in menstrual migraine trial, expanding its potential market.
Alzheon outlines plans for major fundraising round despite Phase 3 miss for Alzheimer's drug — latest biopharma news.
Disc Medicine presents a competitive challenge in polycythemia vera, but Silence Therapeutics maintains its lead in the space.
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 — latest biotech and pharma news.
Takeda, Daiichi, Samsung Bio and more—Fierce Pharma Asia — latest pharmaceutical industry news.
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 — latest pharmaceutical industry news.
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 — latest FDA regulatory news.
Encoded raises $275M series F for Dravet syndrome gene therapy
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 — latest FDA regulatory news.
Shionogi's stroke drug fails mid-stage; Bayer's Hyrnuo gets expanded label in NSCLC
The blueprint for clinical AI
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
News from BioPharma Dive: A new immuno-oncology play raises $225M for a next-generation drug
News from STAT News: AMA CEO: AI won’t replace doctors — it will work alongside them
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
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
News from Fierce Biotech: Evommune gives up on dermatitis drug after another ph. 2 fail
News from BioPharma Dive: FDA gains continuity as Mikhail, Davis named permanent CBER, CDER leaders
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
Sandoz plans ‘vast and vertically integrated’ supply chain to support 100-biosimilar vision
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
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
Novartis’ cholesterol-lowering medicine fails Phase 3, clouding Lp(a) horizons
Reeling from past failures, Parkinson’s pipeline enters ‘era of diversification’
Roche sweeps neurology corporate reputation rankings once again
News from Endpoints News: BrainChild Bio gets $116M for pivotal trial of pediatric brain tumor CAR-T
A new blood pressure monitor from CART demonstrates clinical utility for monitoring patients with atrial fibrillation and heart failure.
News from Endpoints News: Moonwalk raises $70M to test siRNA treatment for obesity
Novartis' Phase 3 pelacarsen study miss in cardiovascular disease raises competitive stakes for Amgen and Eli Lilly in the space.
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
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
FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
NeuShen Therapeutics, founded by former I-Mab CEO Joan Shen, raises over $80 million to develop three brain-health drug candidates.
Article from Fierce Biotech about Invivyd's chair adds CEO role ahead of readout—Chutes & Ladders.
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
Article from STAT News about The FDA removed the red tape around one of the best drugs for children with schizophrenia. But the f.
A CBER official overruled the review team's rejection of Replimune's new melanoma drug, raising questions about FDA decision-making.
Patient deaths in a Novartis CAR-T cell therapy trial raise fundamental questions about acceptable risk in autoimmune disease treatment.
Article from Fierce Pharma about Novartis teams with Olympian Laviai Nielsen on MS campaign.
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
Summit, Akeso’s ivonescimab bests Merck’s Keytruda in China trial—again
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’s ‘high-risk’ Angelman bet fails, cratering stock and forcing strategic review
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)
FDA Allows First Gene Therapy Clinical Trial for Ultra-Rare Pediatric Neurodegenerative Disease
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
Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing
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'. Published by Endpoints News on 2026-09-01.
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
North Carolina Approves Reimbursement of VR Therapy for Neurodivergent Residents Under NC Innovations Waiver. Published by PR Newswire FDA on 2026-09-01.
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
Arrowhead claims safety edge over Ionis as triglyceride battle draws closer
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
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. Published by Fierce Biotech on 2026-08-31.
Emergent spreads overdose awareness campaign across US, Canada. Published by Fierce Pharma on 2026-08-31.
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. 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. Published by PR Newswire FDA on 2026-08-31.
Novartis pushes ahead with its IL-6 inhibitor despite Novo's failure
Federal autism advisory committee members reiterate discredited theories about autism causation, raising concerns among scientists and patient advocates.
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
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
We quit the CDC last year. The problems we protested remain
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
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. Published by STAT News on 2026-08-27.
Summit, Akeso tout biliary cancer win for PD-1/VEGF in China—but details are pending
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
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
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
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
EyePoint plummets on pivotal data for main drug
FDA extends review of Capricor cell therapy; Pain drug startup to go public
Lundbeck partners with Eversana to broaden AI scope
NAD reaches split decision on Kenvue-Hims & Hers hair ad row
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
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
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
Medicine stopped shaking hands. We should start again
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
TME's hunt for partner for brain cancer nears conclusion
AI, genomics expert leaves Pathos AI, will advise Pfizer
AI in Pharmacovigilance: Why Governance Will Define Success
Ambros Therapeutics’ Path for Pain Drug Goes Through Reverse Merger With Werewolf
Chronic pain biotech co-founded by Vivek Ramaswamy joins reverse merger train
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
How Lundbeck’s CEO aims to keep firm ‘punching above its weight’
Novo Nordisk starts trialing lower maintenance doses of oral Wegovy
Pheast’s CEO has no regrets despite competitors gaining an edge
Regulatory tracker: J&J, Ono, LIB Therapeutics gain approvals
Trump taps White House aide Heidi Overton to lead FDA
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
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
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
Ultragenyx bags first gene therapy approval as previously rejected Sanfilippo asset awaits decision
Xspray's Dasynoc knocked back by FDA over production once again
AI has created a shadow medical system
Human brain organoids model development for 5 years
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
VIEW Moderna-Merck melanoma vaccine data boosts outlook, but analysts await full results
Biotech's reverse merger renaissance poised to continue
Latest PR Newswire FDA coverage of Consano Bio Receives FDA Fast Track Designation for C-1101 in Chronic, Painful L
Latest PR Newswire FDA coverage of Enlil Unveils Governed AI Foundation to Ready Medical Device Makers for AI-Assis
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
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.
Endpoints News reports Celcuity is awaiting FDA review of a second manufacturing facility to support commercial launch of its cancer drug.
Fierce Biotech reports Evaxion scrapped its solid tumor vaccine program to focus on a Duke-partnered brain cancer candidate.
Reuters reports EyePoint's eye drug missed its main goal in a late-stage trial, sending shares tumbling.
BioSpace reports EyePoint Pharmaceuticals stock dropped sharply after its Phase 3 AMD drug failed, intensifying the next-generation macular degeneration competition.
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.
PR Newswire reports Nolla Health expanded its medical advisory board and clinical leadership team to advance its AI-powered healthcare platform.
Opinion piece arguing that paid paternity leave functions as preventive pediatric care.
Latest Fierce Pharma coverage of Quanovate scratches marketing claims for Mira fertility wand
Reuters reports Sandoz will license three biosimilar drugs from Shanghai Henlius Biotech, expanding its biosimilars portfolio.
Fierce Biotech reports Slate Medicines used Fulcrum Therapeutics' Vault reverse merger vehicle to join Nasdaq with $245M for migraine trials.
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.
Endpoints News reports Abcuro raised $66M to advance its Phase 3 program in a muscle-weakening condition.
Endpoints News reports Cytokinetics filed a patent infringement lawsuit against Bristol Myers Squibb, escalating competition in the cardiac myosin modulator space.
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 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.
Endpoints News reports Redx Pharma is pursuing another reverse merger, this time with Skye Bioscience, as biotechs increasingly turn to alternative listing routes.
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
/PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the U.S. Food and Drug Administration (FDA) has approved ziresovir...
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.
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 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.
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.
/PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology,...
/PRNewswire/ -- Aidoc today announced that the Centers for Medicare & Medicaid Services (CMS) has approved a New Technology Add-on Payment (NTAP) for the CARE™...
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
/PRNewswire/ -- Perimeter Medical Imaging AI, Inc. ("Perimeter" or the "Company") (TSXV: PINK) (OTCQX: PYNKF), a commercial-stage medical technology company,...
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
Abbott is again tapping into the competitive spirit of Big Ten universities to drive blood donations,
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 secure lung cancer victory to challenge J&J
Taiho, Cullinan's lung cancer drug passes Phase 3 test, lining up Rybrevant contest
Trump nominates policy aide Overton to lead FDA
Zealand's royalty deal; Khartis raises money for TED drug
After trimming headcount, Aardvark drops trials as wait drags on
AI clinical trial agent delivers up to 82 times ROI in oncology
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
Two health insurers give an AI reality check
With tech backing, AI biotechs force biopharma into ‘fail-fast’ drug development
Abbott, Google Health team up on AI-powered health insights app
Bristol Myers details new $2.3B manufacturing campus in Houston
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
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
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
Novo Nordisk's Awiqli®, the first once-weekly basal insulin for adults with type 2 diabetes, now available in the US
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
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
Jazz bets on epilepsy again by acquiring Actio for $820M upfront
Novo and Amazon sign drug discovery pact, launch innovation hub
Pathos AI signs two cancer deals with Alphamab and AZ
Sionna’s cystic fibrosis failure is a windfall for Vertex’s blockbuster franchise
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
Trump administration tries again to institute rebates in 340B
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
Takeda, Daiichi, Astellas and more—Fierce Pharma Asia
Actimed Therapeutics has regained rights to its cachexia drug after terminating its $126 million deal with Faraday Pharmaceuticals.
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 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.
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
LifeMine revived by $188M fundraise backed by Gates and Bezos
Sanofi has been asked to change its Dupixent advertising after a challenge from Galderma over the campaign's claims.
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
ViiV Healthcare is rolling out a new long-acting HIV campaign aimed at 'future you', promoting its long-acting treatment options.
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.
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
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
Eli Lilly is dropping another gene therapy program acquired in its roughly $1 billion Prevail Therapeutics buyout, extending a series of portfolio reductions.
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
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.
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
Gilead prevailed in a yearslong HIV drug innovation lawsuit after the California Supreme Court ruled drugmakers have no duty to innovate.
Contract research organization Icon has partnered with Anthropic to deploy its Claude AI assistant across clinical trial operations.
Jazz Pharmaceuticals will withdraw Zepzelca from the second-line small cell lung cancer setting after a confirmatory trial failure.
Latigo Biotherapeutics has set terms for a $247 million IPO to fund its non-opioid pain drug rival to Vertex's Journavx.
Lisata Therapeutics is cutting 72% of its staff and suing Kuva after their planned merger fell through.
AI-enabled oncology biotech Pathos AI signed back-to-back cancer deals with AstraZeneca and China's Alphamab worth up to $2.2 billion.
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.
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 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.
Patients often get weaker waiting in the hospital for heart transplant. A cardiologist had an idea: inpatient prehabilitation.
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 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
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
Jazz Pharma Expands Again in Epilepsy With $820M Actio Bio Acquisition
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
Novo Nordisk's cardiovascular pipeline suffered a late-stage clinical failure, a setback for the company's expansion beyond diabetes and obesity.
Pathos AI picked up two cancer drugs poised for clinical development, applying AI agents to drive the work forward.
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 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
AbbVie raised its full-year sales guidance on the strength of Skyrizi, whose momentum is holding up against Johnson & Johnson's rival drug Icotyde.
Latest MedCity News coverage of Slate Medicines' Merger and $245M Private Placement Fuel Mission in Migraine
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 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
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
Daiichi Sankyo flags accounting error; shares tank
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
HIV resurgence looming as international aid declines
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 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%
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
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
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. Reported by Endpoints News on 2026-07-30.
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
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. Reported by STAT News on 2026-07-30.
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. Reported by Endpoints News on 2026-07-30.
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
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
Ten years after WHO recognition, mycetoma remains one of the world’s most neglected diseases. Reported by STAT News on 2026-07-30.
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 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.
Biopharma marketing agency CG Life merged with AI-driven branding firm The Considered+AI to broaden its AI capabilities for life-sciences clients.
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. Reported by BioSpace on 2026-07-29.
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 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
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
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. Reported by Endpoints News on 2026-07-29.
Moderna maintains 10% growth target despite Phase 3 norovirus miss
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. Reported by BioSpace on 2026-07-29.
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. Reported by Endpoints News on 2026-07-29.
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. Reported by BioSpace on 2026-07-29.
Teva executives said the company's branded and biosimilar growth plus cost discipline are offsetting continued generic price erosion in Q2.
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 paid AbCellera Biologics $28 million upfront under a new multi-target antibody discovery deal aimed at autoimmune T-cell engager (TCE) programs.
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
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®.
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. Reported by Endpoints News on 2026-07-28.
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.
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.
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.
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.
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.
BMS, NVIDIA to build 'most powerful' AI factory.
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.
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. Reported by BioSpace on 2026-07-27.
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 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 (odevixibat) failed a Phase 3 trial in biliary atresia, the latest setback for the Albireo portfolio acquired in 2021.
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.
Ipsen's liver disease drug Bylvay fails biliary atresia trial.
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 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.
Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study.
The U.S. pharmaceutical supply chain problem is not about China.
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 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 tools across U.S. hospitals.
VELMENI Receives FDA 510(k) Clearance for AI-Powered 3D CBCT Dental Imaging Software.
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 a pivotal China trial for its transcatheter pulmonary valve technology.
Agios Pharmaceuticals said tebapivat fell short of expectations in a Phase 2 test in sickle cell disease.
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 raised $130M to advance its Sobi-rivaling gout drug through Phase 3 testing.
Crystalys raised $130M to push its gout drug dotinurad through late-stage testing.
Crystalys raised a $130M series B to push its gout drug through phase 3 testing.
Dimension raised $800M for its third fund to capitalize on AI's 'rapid ascent' in biotech.
Kaken has revealed the data that supported its recent marketing application for serabelisib as a treatment for vascular malformations in Japan.
Mentari raised $200M for its migraine program while Royalty Pharma announced a new ATTR-CM deal.
NIH joins the White House's $5B artificial intelligence "Genesis Mission" with a biomedical research push and expanded AI compute.
Precision Neuroscience has shown that people can control electronic devices with thought alone, without electrodes implanted in the brain.
Ashlins Pharma has licensed a Chinese formulation of a well-known medicine and set its sights on a $50 million fundraise.
Sanofi receives an FDA untitled letter calling out Beyfortus (nirsevimab) promotional emails as misleading.
In the latest ivonescimab survival data, 'most western patients have now discontinued treatment or completed two years of treatment,' Summit said.
Valion Bio announced that Ukraine's Ministry of Health accepted the Company's regulatory dossier for Entolimod.
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 said adios to its sickle cell program over lackluster Phase 2 data.
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.
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.
GSK is shelving its cough drug camlipixant that it acquired in a $2 billion deal.
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?
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.
Pain drugmaker Latigo outlined plans to go public on NASDAQ under ticker LTGO.
Eli Lilly agreed to buy AtaiBeckley for $2.8 billion, further validating psychedelics research.
Lupin seeds US spinout with cash, clinical-stage cancer assets.
Moderna says CureVac broke agreement by suing over COVID vaccine patents.
New center launches for personalized genetic therapies.
Notes from a peptide meetup.
Novartis CEO shrugs off oral PCSK9 threat amid Q2 growth.
Novartis drops ph. 2-stage radioligand therapy over poor data.
Novartis stays ‘geography-agnostic’ in dealmaking amid flurry of China deals.
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.
Science and the public are learning the wrong lessons from Covid.
Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab.
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.
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.
UnitedHealth Group lays out progress in AI push.
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.
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.
Bayer's Kerendia on course for NHS use in heart failure.
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.
FDA’s radical transparency policy for rejections runs into legal uncertainty.
J&J, Time to name Healthcare Champion of the Year.
Kolon’s cell-based gene therapy fails ph.3 osteoarthritis test.
Lilly buys into psychedelics with $3.8bn AtaiBeckley deal.
Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics.
Rebel Wilson talks losing weight 'for keeps' in Noom campaign.
Samsung Bio set to launch $1.8B buyout of Swiss CDMO PolyPeptide.
Sanofi survey reveals diabetes misconceptions and screening gaps.
Scribe aims for $96M IPO to fund lipid-lowering genetic meds.
Why Legend Biotech stock fell 10% despite record Carvykti sales.
Midsized biotechs take case against CMS' GLOBE and GUARD models to White House.
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.
Sonathera claims ultrasound can unlock the power of gene therapy in Duchenne and other diseases.
GSK discontinues its Phase 3 chronic cough program from the $2B Bellus Health acquisition.
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 returns to releasing pharma rejection letters with 14 new CRLs.
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
BioPharma Dive survey of how AI-discovered drugs from Insilico, Recursion, Verge are faring in the clinic.
Huahai hires Hengrui's quality chief amid FDA manufacturing citations.
Lilly bets $2.8B upfront on psychedelics in the AtaiBeckley acquisition.
Lilly bets $2.8B upfront on psychedelics in the AtaiBeckley acquisition.
Lilly inks $2.8B AtaiBeckley psychedelic buyout to challenge J&J
Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeover
Jennifer Doudna enters the AI protein design arena with a new venture.
Raidium Brings AI-Powered Oncology Imaging Workflow to US Cancer Centers
Radiopharma maker AdvanCell raises $315M for a Pluvicto challenger.
US drug shortages rise for third straight quarter, hurt by lone suppliers.
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
Amid $55B US manufacturing push, J&J turns to streamlining its pharma supply chain
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
Bora inks $2.5B deal with drug discovery AI specialist Insilico
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
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
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
Q32 bounces back to claim study success for alopecia drug
Standing out, not blending in: how AI tools can drive impact during job searches. Reported by BioSpace on 2026-07-15.
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.
Veradermics reports female-pattern hair loss results for its oral minoxidil baldness drug.
Veradermics reports ph. 2 win in female pattern hair loss
With $315M raise, AdvanCell puts radiotherapy pedal to the metal
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
/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 Discovery raises $400M, tripling its valuation in seven months.
Draig bags another $65M to speed testing of brain drugs
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 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
/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
Summit sells failed antibiotic to OpenAI-backed startup
BioSpace feature on emerging opioid alternatives for pain relief.
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 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.
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
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.
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.
Through the proposal, the FDA could clear barriers to distributed manufacturing approaches intended to enhance emergency preparedness and supply chain resilience.
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
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 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 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 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 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
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
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 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 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.
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
BioSpace reports: AstraZeneca, Ionis’ Wainua woes send waves across ATTR-CM space.
Fierce Pharma reports: AZ's China deals, Kailera-Hengrui—Fierce Pharma Asia.
Fierce Biotech reports: Bausch + Lomb gives up on glaucoma eye drop hopeful after fail.
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.
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 (BioSpace.)
AstraZeneca's Wainua fails key heart disease trial, shares tumble
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
BioPharma Dive reports: GSK ends brain drug alliance with Alector.
Ipsen’s Botox rival Dysport posts dual ph. 3 wins in migraine (Fierce Pharma.)
BioPharma Dive reports: Kailera says obesity pill succeeds in late-stage trial in China.
BioPharma Dive reports: Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal.
BioSpace reports: Psychedelics surge again as Compass, Definium provide more clinical validation.
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 (reported by BioSpace)
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 (Fierce Pharma.)
Novartis slashes New Jersey workforce again, cutting 322 employees (reported by BioSpace)
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 (reported by BioSpace)
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 (reported by BioSpace)
AI care partner Heidi touts positive side effects in campaign (reported by Fierce Pharma)
BMS details Krazati confirmatory fail in colorectal cancer (reported by Fierce Pharma)
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 (reported by PR Newswire)
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 (reported by BioSpace)
Anthropic launches Claude Science for pharma researchers. (Pharmaphorum.)
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 — Endpoints News coverage of biopharma industry developments.
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.
When clinical AI gets real — Endpoints News coverage of biopharma industry developments.
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
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
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
Lilly Expands Its Mind to Psychedelics With $2.8B AtaiBeckley Acquisition.
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
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 — BioSpace coverage of biopharma industry developments.
Tenpoint brings blurry vision hassles to life in new campaign. (Fierce Pharma.)
The Measurement Problem Behind Two Decades of Neurology Trial Failures
The top biopharma conferences remaining in 2026. (BioPharma Dive.)
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.
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 (MedCity News.)
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
Evommune is discontinuing development of its lead chronic spontaneous urticaria candidate after a mid-stage trial failed to meet efficacy benchmarks.
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 (BioPharma Dive.)
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.
Endpoints News reports that Evommune's lead clinical candidate failed to meet primary endpoints in chronic hives, sending shares down on the readout.
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 (STAT News.)
BIO 2026: Making biotech IPOs great again and the forgotten pharma antitrust review
EC begins antitrust probe into Sanofi's flu shot campaign.
EU Commission opens antitrust probe into Sanofi's flu vaccine campaign
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.
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.
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
Methadone for opioid addiction has been available only at specialty clinics. A bipartisan bill would greatly expand access.
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.
Supreme Court ruling blocks thousands of lawsuits against maker of Roundup weedkiller.
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;…
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.
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.
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
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 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.
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.
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. (Reuters Biopharma.)
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.
EU probes Sanofi for alleged smear campaign against rival flu vaccine.
Brent Saunders' latest dermatology startup raised $20M to develop skin longevity therapeutics, marking his return to the specialty he built Allergen around.
Flagship Pioneering's Abiologics emerged from stealth, using AI to design mirror-image proteins as a new modality for drug development.
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.
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.
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 Pharmaceuticals signed a deal worth up to $1.4B with Haisco Pharmaceutical for two late-stage oncology programs.
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 acquisition faced another setback as a key ADC failed in late-stage lung cancer trials, raising fresh questions about the deal's strategic value.
Federal prosecutors charged a Texas doctor in an $89M healthcare fraud case as the Trump administration intensifies its crackdown on Medicare and Medicaid fraud.
New Medicaid work requirements create a Catch-22 for disabled workers who lack medical proof of their disability, threatening to strip them of coverage.
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.
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.
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.
AH-008 Achieves Dual Regulatory Milestones with U.S. FDA IND Clearance and Taiwan CDE Index Case Designation AnHorn Medicines
Alnylam Pharmaceuticals faces regulatory scrutiny over promotional practices following a complaint by Pfizer.
Alnylam drew regulatory scrutiny over its promotional activity after a complaint from Pfizer, highlighting ongoing tension between innovators and generic / biosimilar competitors.
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.
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 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 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 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.
Fierce Biotech details the rapid-fire negotiations behind Pfizer's $10 billion deal with Innovent Biologics.
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.
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 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.
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.
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 is cutting 340B drug pricing to hospitals that fail to comply with its claims data policy.
Lilly's TuneLab AI platform has crossed the 100-member mark and added AI models from Chai.
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 a major AI-powered drug discovery collaboration worth potentially $2.5 billion+, leveraging Insilico's AI drug discovery platform to develop novel therapeutics.
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.
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.
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 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 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 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.
Triveni Bio raises $65M ahead of upcoming readouts on its eczema drug programs, advancing its antibody-based pipeline for immune and inflammatory diseases.
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.
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 emerged from stealth with $46M Series A financing (co-led by Westlake BioPartners and Canaan Partners) to advance next-generation therapies for migraine prevention.
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.
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.
The FDA expanded access to over-the-counter naloxone nasal spray, making the opioid-overdose reversal agent more widely available without a prescription.
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.
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.
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 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 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 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 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.
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.
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 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.
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 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.
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.
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.
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 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.
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.
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.
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 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.
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 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.
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.
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 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 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 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.
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 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.
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 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 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.
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.
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.
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 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 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.
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 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.
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, 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 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.
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.
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.
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 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.
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 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 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.
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.
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.
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 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 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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
Therapeutics developers leveraging computational biology and AI foundation models as core pipelines.
Profile of Abiologics created from news harvest. To be enriched by user.
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
Abridge 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).
Biopharmaceutical company. AI / Machine Learning
Aidoc 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.
Alto 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.
Autonomous 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.
Avenda Health is a ai-enabled medical devices company. See today's news for the latest developments.
Basecamp 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.
AI software/electroencephalography for neuro biomarker discovery
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)
BioXcel Therapeutics is a clinical-stage biopharmaceutical company leveraging artificial-intelligence–driven drug discovery to develop neuroscience and immuno-oncology medicines. Its lead commercial product IGALMI (sublingual dexmedetomidine) is FDA-approved for acute treatment of agitation associated with schizophrenia or bipolar I/II disorder, with an at-home sNDA under FDA review (PDUFA target action date November 14, 2026). The company is exploring strategic options for the IGALMI franchise after first-quarter 2026 IGALMI net revenue of $206K and an operating loss of $10.2M. Shareholders have previously authorized a 1-for-2 to 1-for-20 reverse split range to maintain Nasdaq bid-price compliance. On August 27, 2026 BioXcel and its subsidiaries filed for Chapter 11 bankruptcy in Delaware; on August 31 the company secured a super-priority debtor-in-possession credit facility of up to $77.25 million from Oaktree Capital affiliates and existing lenders, and Nasdaq has notified it of delisting with trading suspended effective September 8, 2026.
Peptide Libraries for AI Cancer Drug Discovery
Oxford University spinout developing AI-powered imaging biomarkers for stroke, lung cancer and pulmonary fibrosis. FDA cleared.
Profile of Cadence created from news harvest. To be enriched by user.
Precision cardiovascular medicine company offering AI-driven genetic-epigenetic technology for heart attack risk assessment and disease prevention. Public company (NASDAQ: CDIO).
Denali 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.
Dogwood 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.
Governed AI foundation platform for medical device manufacturers, enabling regulatory-compliant AI integration in healthcare.
Ensysce 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.
Enveda 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.
Evaxion 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.
Formation 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.
Generate 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).
HeartSciences 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.
AI-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.
ICON 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.
Insilico Medicine is an end-to-end generative artificial intelligence-driven drug discovery company connecting biology, chemistry, and clinical trials analysis.
Medtech company developing NIO Laser Imaging System, using stimulated Raman histology for intraoperative fresh tissue imaging, plus AI-based image analysis for cancer detection.
Clinical-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.
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
Lunai 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.
AI-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.
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.
Real 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.
Services: AI-driven preclinical cancer drug development; organoid-based drug discovery; FDA Fast Track designation | Leadership: — | Keywords: AI, organoids, cancer, targeted therapy, gastric cancer
Silexion 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.
SimBioSys 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.
Slate 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.
Tempus 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.
Enterprise-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.
Verge 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.
AI-driven drug discovery company applying generative models and machine learning to small molecule and biologics design.
Software platforms, digital notebooks, and LIMS offering GxP-compliant AI-powered co-pilots and analytics.
10x 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.
Accruent 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.
Arena 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.
Aspen 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.
Blue 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.
ComplianceQuest 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.
Dotmatics 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.
eLabNext 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.
eMaint 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.
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.
ETQ 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.
Greenlight 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.
IQVIA 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.
LabArchives 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.
MaintainX 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.
MasterControl 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.
Mettler-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.
Qualio 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.
Sapio 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.
SciNote 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.
Scispot 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.
Seal (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.
Veeva 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.
ZenQMS 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.