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903 stories matching this filter · ← front page

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  • Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workers
    Hundreds of executives and investors are pushing for Rick Pazdur to be the next FDA commissioner. Elsewhere, Takeda detailed its latest restructuring and Alumis is discarding a once-highly touted i…
    BioPharma Dive · 2mo ago↗ source
  • Candel reports prostate cancer drug's long-term data ahead of FDA filing
    Candel Therapeutics produced long-term follow-up data that may bolster the case for its prostate cancer drug that's heading to the FDA for marketing approval later this year. The company followed u…
    Endpoints · 2mo ago↗ source
  • Post-Hoc Live: Makary's out at FDA and what comes next
    Marty Makary resigned as FDA commissioner on Tuesday after a turbulent tenure at the head of the agency. Makary was scheduled to sit down with senior reporter Max Bayer this week at ...
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fda medwatch21
fda recalls18
Psychiatry & CNS87
Ophthalmology86
Pain75
Endocrinology & Metabolism52
Dermatology51
Endpoints · 2mo ago
↗ source
  • Aardvark's next move after clinical hold; Alumis' verdict on Acelyrin asset
    Plus, news about Tenaya’s TN-401 and Taiho’s Inqovi. 📉 Aardvark to unblind rare disease trial following clinical hold: The FDA has placed a full clinical hold on the company's candidate for ...
    Endpoints · 2mo ago↗ source
  • India’s pharma industry is going global. But can it catch up to China?
    A record Sun Pharma acquisition signals global ambitions. But infrastructure, capital and policy gaps could stand in the way of India becoming an R&D powerhouse.
    BioPharma Dive · 2mo ago↗ source
  • M&A isn’t just for big pharma. Mid-size companies are stepping up deal hunts
    In what is shaping up to be one of the most active years for biopharma M&A on record, a different-looking set of buyers is going shopping. Mid-cap American drugmakers, family-owned pharma groups, f…
    Endpoints · 2mo ago↗ source
  • Andrea Pfeifer ends 23-year reign at AC Immune; Acadia's top R&D exec announces retirement
    AC Immune will be searching for a new CEO for the first time, as the company announced this week that Andrea Pfeifer plans to retire after 23 years at the helm. ...
    Endpoints · 2mo ago↗ source
  • #ASGCT26: A Zillow-like marketplace for abandoned gene therapies goes live
    BOSTON — Two nonprofit organizations have devised a plan to help abandoned cell and gene therapies find a new home. On Thursday, the American Society of Gene & Cell Therapy (ASGCT) and the Orphan T…
    Endpoints · 2mo ago↗ source
  • Supreme Court preserves mail access for abortion pill
    The Supreme Court will continue to allow the abortion pill mifepristone to be distributed by mail, at least for now. The Thursday ruling maintains mifepristone's current safety protocols while liti…
    Endpoints · 2mo ago↗ source
  • #ASGCT26: Encoded's gene therapy reduced seizures in Dravet syndrome
    A gene therapy designed by Encoded Therapeutics reduced seizures by 76% in children with Dravet syndrome, a severe neurodevelopmental disorder. The remarkable reduction was observed only in three p…
    Endpoints · 2mo ago↗ source
  • #ASGCT26 dispatch: In vivo CAR-T is everywhere
    BOSTON — Greetings from Boston, where I’ve been on the ground covering the American Society of Gene & Cell Therapy’s annual meeting all week. It’s a crucial moment for the field. Genetic medicine d…
    Endpoints · 2mo ago↗ source
  • Create Medicines raises $122M to bolster in vivo CAR-T therapies
    The fresh funds will support the biotech's pipeline of RNA-based CAR-T cell therapies for cancer and autoimmune conditions.
    BioPharma Dive · 2mo ago↗ source
  • Drugmakers have to go through rigorous tests to get a lower tariff rate
    Landing a reduced 20% tariff rate will require pharma companies to fill out extensive paperwork and be closely monitored by the Department of Commerce. President Donald Trump signed an executive or…
    Endpoints · 2mo ago↗ source
  • Biogen pushing tau drug forward despite Alzheimer’s study failure
    One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.
    BioPharma Dive · 2mo ago↗ source
  • Degron, CREATE, TenNor raise capital; Cabaletta posts CAR-T data
    💸 A Series A extension: US-China biotech Degron Therapeutics has collected an additional $40 million for its molecular glue degrader platform. The San Diego and Shanghai biotech has raised $95 mil…
    Endpoints · 2mo ago↗ source
  • AstraZeneca follows Merck with Phase 3 win in bladder cancer
    A combination of AstraZeneca's Imfinzi with Pfizer and Astellas’ Padcev kept more bladder cancer patients alive than standard of care, the company said Thursday. AstraZeneca said it would seek appr…
    Endpoints · 2mo ago↗ source
  • MacroGenics sells manufacturing arm; West Pharma discloses cybersecurity attack
    Plus, news about Bavarian Nordic and OrganaBio’s new CDMO subsidiary: 🏭 Bora buys MacroGenics' manufacturing operations: MacroGenics is selling its clinical and commercial drug substance productio…
    Endpoints · 2mo ago↗ source
  • With new data, Regenxbio to seek FDA approval of Duchenne gene therapy
    Though two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease flexibility.”
    BioPharma Dive · 2mo ago↗ source
  • How Penn Medicine plans to use AI to train their doctors
    Physicians at Penn Medicine said they're thinking of how to use AI to train doctors. The idea came out of a $1.1 million grant Penn Medicine won in January through an education grant program with ...
    Endpoints · 2mo ago↗ source
  • Biogen's anti-tau Alzheimer's drug misses Phase 2 goal, but claims signs of efficacy
    Here we go again? Biogen reported heavily anticipated Alzheimer’s data, saying its tau-targeting drug BIIB080 missed its primary endpoint in a Phase 2 study but slowed patients’ clinical decline at…
    Endpoints · 2mo ago↗ source
  • Regenxbio hits Duchenne gene therapy milestone, eyes 2027 FDA approval
    Regenxbio said Thursday that its Duchenne muscular dystrophy gene therapy met the bar in a pivotal study, and it’s aiming for FDA approval in 2027. The biotech hopes to be the second company to com…
    Endpoints · 2mo ago↗ source
  • BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at Venclexta
    BeOne Medicines has clinched an accelerated approval for its drug sonrotoclax in mantle cell lymphoma (MCL), marking the start of its bid to challenge AbbVie and Roche's Venclexta across a range of…
    Endpoints · 2mo ago↗ source
  • #ASGCT26: After an apparent cure, a gene editing company struggles to repeat the magic
    BOSTON — Early last year, startup iECURE’s experimental gene therapy seemingly cured a baby of a life-threatening genetic disease. But new results testing the same therapy in a larger number of bab…
    Endpoints · 2mo ago↗ source
  • Takeda to target 4,500 jobs as incoming CEO continues restructuring
    Takeda will cut roughly 9% of its workforce over the next fiscal year as the next CEO puts her stamp on a yearslong restructuring. About 4,500 roles will be affected, the company said Wednesday in ...
    Endpoints · 2mo ago↗ source
  • Valneva to cut up to 15% of jobs as reduced travel hits vaccine demand
    French vaccine maker Valneva is laying off 10% to 15% of its workforce and reducing revenue projections due to "an emerging adverse trend in travel vaccine uptake across key markets." The drugmaker
    Endpoints · 2mo ago↗ source