The definitive intelligence hub for biopharmaceuticals, clinical developments, stock market indicators, and biotechnology careers.
RingConn's smart ring has received FDA 510(k) clearance for non-invasive blood oxygen (SpO2) measurement, positioning the wearable as a cleared consumer health device for continuous oxygen tracking.
A Takeda spinout builds case for its Parkinson's drug
Click claims FDA okay for first-in-class schizophrenia DTx
FDA review documents for Revolution Medicines' newly approved Rasonque are keeping investors jittery over KRAS-subgroup data as the company works to establish the drug in pancreatic and lung cancer.
GSK drinks in Chai’s AI models after wet-lab validation
GSK is committing $800 million to expand its R&D and manufacturing footprint in Pennsylvania, deepening its US investment as pharma manufacturers face pressure to onshore production.
Halozyme prevails in patent fight with Merck; Enliven readies anticipated leukemia trial
Specialty infusion provider LUX Infusion is broadening patient access to Qfitlia (fitusiran), extending its hemophilia and rare-disease care network.
Quince Therapeutics has relaunched as IRulya Therapeutics, rebranding around an inhaled pulmonary-disease pipeline following its merger with Orphai Therapeutics, alongside a new C-suite and a move of its Nasdaq listing.
Teva bags long-sought reformulated olanzapine schizophrenia nod
Vir looks to Liu to lead late-stage push—Chutes & Ladders
Alpheus Medical has opened enrollment in a clinical trial evaluating its sonodynamic therapy in butterfly glioblastoma.
Argenx has discontinued a trial of Vyvgart Hytrulo in Sjogren's disease after a futility finding.
Argenx reported a Phase 2 win in celiac disease for a drug the headline values at $2.2 billion, teeing up a pivotal study.
CSL Seqirus blasted for ‘multiple and prolonged deficiencies’
AI drug-discovery company Iambic Therapeutics is aiming for a $135 million IPO to advance its cancer programs into the clinic.
Lupin Receives U.S. FDA Approval for Phytonadione Injectable Emulsion, USP
A Dutch court has barred Merck from manufacturing its subcutaneous formulation of Keytruda in eight European countries, a ruling tied to the company's patent dispute with Halozyme over drug-delivery technology.
Newron Pharmaceuticals disclosed five deaths in the late-stage trial of its schizophrenia program as an FDA clinical hold remains in place.
Ono Pharmaceutical is paying $80 million for regional rights to three Biohaven IgG degrader programs, including a Phase 3 Graves' disease asset.
Pfizer's Tukysa has been cleared for earlier use in the treatment of breast cancer.
Saol Therapeutics has completed patient enrollment in the pivotal Phase III BEACON trial of SL1002 in chronic pain associated with knee osteoarthritis.
Theramex is paying $250 million for rights to Cevira, Asieris' drug-device treatment for cervical lesions.
Viatris is acquiring Pacira BioSciences in a $1.65 billion deal that adds non-opioid pain-management products to its portfolio.
Wellysis has received FDA 510(k) clearance for S-Patch CardioAI, an AI-powered ECG analysis software.
The 2026 Nobel Prize in Chemistry was awarded for research on 'mirror image' molecules, work with direct implications for pharmacology and drug design.
A look at the five largest venture capital raises in biopharma during the third quarter of 2026.
AbbVie's telisotuzumab adizutecan (Temab-A) received two FDA Breakthrough Therapy Designations, in colorectal cancer and non-small cell lung cancer.
AMO Pharma, with the Population Health Research Institute and Venca Research, announced FDA advice on a potential Phase 3 development path for AMO-02 in arrhythmogenic cardiomyopathy.
ArriVent shares fell sharply after a late-stage lung cancer trial miss.
Atsena Therapeutics reported a gene therapy readout that illuminates efficacy in eye disease.
Cadrenal Therapeutics has launched a strategic review of its late-stage cardiology pipeline.
Catalent won access to IRO and launched a next-generation development platform.
Cerevance's Parkinson's disease drug shortened 'off time' in a Phase 3 trial, paving a path toward FDA review.
CraniUS Therapeutics won a second FDA 510(k) clearance in six weeks and a U.S. patent for its NeuroPass-3 cranial drug delivery system.
Dignify Therapeutics received FDA clearance of an IND for DTI-117, moving its neurogenic bowel dysfunction program into the clinic.
Caribou Biosciences, the CAR-T biotech co-founded by Jennifer Doudna, is ending R&D activities and cutting staff as financing conditions tighten.
European biotech leaders say optimism is returning to the sector.
Matchpoint Therapeutics raised a $150M Series B to take its covalent medicine into the clinic.
MimiVax's glioblastoma vaccine missed its primary endpoint in a Phase 2 trial.
European regulators have ordered MSD to pull the injectable formulation of Keytruda from sale in Europe.
Novartis has secured an FDA expansion for Rhapsido covering the two most common forms of chronic hives.
Okami Medical's LOBO vascular occluder has received an expanded FDA indication.
Third-quarter biopharma layoffs fell year over year, with 90% fewer employees affected than in the prior-year period.
Sonorous Neurovascular has received FDA IDE approval for the first U.S. pivotal trial of its venous sinus stent in pulsatile tinnitus.
TCGX launched a $600M fund to back Asian biotech companies.
The UK medicines watchdog has taken its first enforcement action over advertising of oral weight-loss drugs.
AbbVie and Genmab are touting a much-anticipated first-line win for | Epkinly plus R-CHOP cut the risk of progression or death by 51% compared with R-CHOP alone in newly diagnosed DLBCL, setting up a potential first-line challenge to Roche’s Polivy.
AbbVie and Genmab’s bispecific antibody blew analyst expectations out of the water with a 51% improvement in progression-free survival when used alongside a standard frontline regimen in diffuse large B cell lymphoma—potentially setting up a battle with Roche's Polivy.
The first drug from AbbVie's $8.7 billion takeover of Cerevel two years ago, Parkinson's disease therapy Juvmo, has won FDA approval.
The error points to a big question for pharma as AI gains autonomy and high-profile failures sharpen safety concerns: What happens when a wrong answer becomes the basis for the next decision?
AstraZeneca's has opened a new R&D centre in the biotech hotspot of Cambridge, Massachusetts, the centrepiece of a $1bn investment in the state.
AZ hopes for 'amazing things' from Kendall Square R&D center.
AstraZeneca has taken a roughly 10% stake in Summit and signed a deal to test CLDN18.2-targeting sone-ve with PD-1xVEGF bispecific ivonescimab.
/PRNewswire/ -- Cala®, the bioelectronic medicine leader, today announced nationwide availability of the Cala kIQ® Plus System, the latest advancement of its...
CSL strikes rare disease drug deal worth up to $1.6 billion with Swiss firm Alentis.
/PRNewswire/ -- Dr. Oregonin Inc. today announced that it has completed U.S. Food and Drug Administration (FDA) registration for OLTIS DENTAL-X, paving the way...
Enliven Therapeutics said the FDA aligned on the ENABLE-2 Phase 3 trial design for relcobatinib (ELVN-001) in previously treated chronic myeloid leukemia.
Sweden's Egetis has won approval in the US for the first-ever treatment for people living with ultra-rare genetic disease MCT8 deficiency.
Despite the regulatory delay, Novo is still expecting a 2027 launch for its hemophilia A drug denecimig.
Fierce Biotech Fundraising Tracker '26:KymaThera, RougeTx & more.
Forbion's 'landmark' €2.3B fundraise to benefit 30 biotechs.
The purchase expands GE HealthCare’s radiopharmaceutical capabilities, helping manufacture and distribute time-sensitive drugs used in PET imaging.
Fifty years ago, Herbert Boyer, Ph.D. and venture capitalist Robert Swanson met for drinks. | Known as the 'original biotech,' Genentech is unlocking its archives to shine light on its past, present and future in a new documentary celebrating its 50 year anniversary.
/PRNewswire/ -- Headlands Research - Summit Portland, a Headlands Research site and medical research organization serving the greater Portland, Oregon area, is...
In the past 18 months, the National Institutes of Health (NIH) has been working overtime to push new policies to reduce animal testing with one woman at the helm: Nicole Kleinstreuer, Ph.D. | In the past 18 months, the National Institutes of Health has been working overtime to push new policies...
Researchers found pulse oximeters went from overestimating blood oxygen levels to underestimating them; inaccuracies were worse in patients of color.
Kairos seizes moment to push cancer asset into earlier setting.
While psychedelic drugs may be capturing all the attention when it comes to finding fresh ways to treat neuropathic pain, research with mice has suggested a peptide approach may also be effective.
Novartis has added a T-cell engager developed by China's Abogen Biosciences for autoimmune disorders in a deal that could be worth over $7.5bn.
In exchange for a $575 million payment up front, Abogen Biosciences will furnish Novartis with access to its RNA technology, including an option to license its lead program ABO-2203.
Nuvig Therapeutics halted development of its lead drug for a rare autoimmune disease.
/PRNewswire/ -- October marks ADHD Awareness Month, shining a light on the need for timely diagnosis and personalized treatment. Vertical Pharmaceuticals is...
Contract supports development and U.S. FDA clearance of the OXOS X3 intended for everyday use at the Point of Need™ in emergency departments, clinics, and...
After early supply bottlenecks throttled its rollout, Novartis’ flagship radioligand therapy Pluvicto entered a rapid growth phase recently, driven by FDA approvals in earlier-stage prostate cancer | Novartis’ flagship radioligand therapy Pluvicto entered a rapid growth phase recently, driven by...
With its acquisition of IntraBio, Shionogi will gain ownership over Aqneursa, which could hit peak global sales of $1 billion across its two indications in Niemann-Pick disease type C and ataxia-telangiectasia, according to Jefferies.
/PRNewswire/ -- GigHz, a physician-founded software and research company, today announced findings from a peer-reviewed study led by its founder, Pouyan...
The UK will accept all 44 proposals made in a recent report on using AI tools in the NHS, including continuous monitoring after deployment.
Shares in Vaxcyte have rocketed on phase 3 trial data for its pneumococcal vaccine VAX-31 that suggests it could take on rivals from Pfizer and MSD.
/PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced that Veeva DQS (Data Quality System) has aggregated and cleaned data for more than 1 million...
ViiV Healthcare is assembling its data package for Cabenuva in a competitive HIV market.
STATus Report travels with STAT's Sarah Todd to check out a new longevity program at New York's Weill Cornell Medicine.
ZEISS Medical Technology will showcase its latest innovations and digital technologies at AAO, including: Connected cataract workflow –ZEISS VERACITY Surgery...
Adecto Pharmaceuticals has ceased operations, while Aviceda Therapeutics is in the process of winding down.
Eli Lilly impressed with its amylin-Zepbound combination data. Elsewhere, Novo demonstrated continued weight loss following a switch to oral and AbbVie and Boehringer gave glimpses into their contenders.
Abbott said the FDA has approved new capabilities for its CardioMEMS HF System, an implantable remote-monitoring sensor for heart failure patients designed to help them take a more active role in managing their condition.
/PRNewswire/ -- AIRS Medical today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for SwiftSight® Body Composition,...
Biogen reported new durability data for its lupus treatment in cutaneous (skin) disease, a result that strengthens the case for its sizable investment in the program.
40 Under 40 honorees’ accomplishments include co-developing the world’s first synthetic biology programming language for mRNA and co-founding and leading a company acquired for $700 million up-front and up to $1.225 billion in total consideration.
BridgeBio is turning to YouTube and partnerships with hip-hop and public-health voices for a new campaign aimed at raising awareness of ATTR-CM, the rare heart condition treated by its drug Attruby.
CSL has agreed to pay up to $1.6 billion to co-develop an Alentis Therapeutics drug for autoimmune disease, pairing the Australian company's commercial reach with a claudin-targeting candidate.
The FDA said it is seeking public input as part of an effort to support research into ibogaine, a psychedelic compound being studied for addiction and other psychiatric uses.
Genentech has signed a deal worth up to $1.27 billion to license a preclinical blood-brain barrier asset from Alector, adding to its neurology pipeline.
Gilead Sciences is taking a step into the wellness space to support patients with chronic diseases by offering resources that go beyond physical health. | Sleep app Calm is helping Gilead achieve its dream of helping its patients through a journey of whole-person health.
/PRNewswire/ -- Issued Patent Advances an AI-Enabled Platform for IV Connector CareHAI Solutions, a medical device company focused on intravenous therapy and...
Introducing Fierce Biotech's 2026 Fierce 15.
Eli Lilly first linked up with Gate Bioscience in July 2025 to leverage the biotech’s “Molecular Gate” engine to treat diseases with high unmet need. Monday’s expansion will add one undisclosed target to the existing agreement, with an option for a second.
The pharma giant cut its partnership after a cancer drug disappointed in testing. Elsewhere, Teva and Samsung Bioepis expanded a partnership and space biotech Varda brought in $251 million.
The 2026 Nobel Prize in Physiology or Medicine has been awarded to a trio of scientists for the discovery of optogenetics, a light-based method for switching neurons on and off that has become a foundational research tool in neuroscience.
Novo Nordisk said its U.S. review of a hemophilia candidate has been extended after the FDA flagged corrections needed at a manufacturing site, pushing back a potential approval decision.
OMLYCLO (omalizumab-igec), described as the first and only FDA-approved interchangeable biosimilar to Xolair, is now commercially available in the United States.
Detailed results are competitive with Dupixent and Ebglyss, but the drug lacks differentiation amid an increasingly competitive landscape, one analyst argued.
/PRNewswire/ -- PRM Pharma, LLC, the NDA holder and marketer of HemiClor® (chlorthalidone tablets, 12.5 mg), and Ingenus Pharmaceuticals, LLC, the developer,...
CEO Matt Gline is juggling Roivant Sciences' first solo drug launch and several maturing programs as the hub-and-spoke company sets its sights on a massive turning point into commercial viability.
Just weeks after IntraBio secured a label expansion for its lead asset Aqneursa, Japanese drugmaker Shionogi is moving in to take the reins. | The acquisition builds on Shionogi’s plans to diversify beyond its anti-infectious disease drug base and to beef up its budding rare disease unit.
Shionogi has agreed to acquire rare-disease specialist IntraBio for about $2 billion, extending the Japanese drugmaker's push beyond its core anti-infective business into neurology.
A surge of consolidation, rising appetite for specialized manufacturing and a shift toward decentralized trials is reshaping Switzerland’s life sciences landscape. From peptide producers to organoid CROs, service providers are scaling and diversifying as global sponsors turn to Swiss hubs for…
/PRNewswire/ -- Talkiatry, the nation
/PRNewswire/ -- Vial, a clinical-stage biotechnology company, today announced that it has dosed the first patient in its Phase 1b clinical study of Vial
Not a month after reports of three deaths in autoimmune trials for Novartis' CAR T cell therapy ignited a debate about the use of these treatments in nonfatal diseases, Kyverna Therapeutics reported data bolstering its case to bring to market the first CAR T for an autoimmune disease.
/PRNewswire/ -- Zydus Lifesciences Limited (Zydus), in partnership with MSN Laboratories Private Limited (MSN), today announced the launch of Riociguat...
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