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44 stories matching this filter · ← front page

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  • Jazz Pharmaceuticals to acquire Actio Biosciences in deal worth over $1.3 billion
    Jazz Pharmaceuticals announced an agreement to purchase Actio Biosciences, a San Diego biotech focused on genetic epilepsies. The transaction could total just over $1.3 billion, with $820 million…
    BioPharma Dive · 1d agoDealPositive↗ source
  • FDA approves Takeda’s orexin-2 drug Orzeyful for narcolepsy type 1
    The U.S. Food and Drug Administration has approved Takeda Pharmaceutical's new sleep medication, Orzeyful, marking the first product in the emerging orexin‑2 drug class. Orzeyful works by amplifyi…
    BioPharma Dive · 5d agoApprovalPositive↗ source
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fda recalls36
fda medwatch24
fda press24
645
Vaccines644
Ophthalmology326
Endocrinology & Metabolism325
Pain309
Infectious Disease301
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda recalls · 6d agoCRLNegative↗ source
  • Supernus and Individor to merge, creating $2 billion brain-drug company
    Supernus and Individor announced a merger that will combine their portfolios of neurological medicines. The two firms together generated about $2 billion in revenue in 2025 from roughly a dozen CN…
    BioPharma Dive · 8d agoDealPositive↗ source
  • Neurologist Who Diagnoses ALS Patients Receives Own Diagnosis, Reflects on Impact of Disability
    Dr. Christopher Campos, a neurologist and assistant professor at UC Davis Health, disclosed that he was diagnosed with amyotrophic lateral sclerosis (ALS) in 2025 after a decade of delivering the s…
    STAT · 8d agoNegative↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 13d agoDealNeutral↗ source
  • Dementia finally shows a viable business model, AAIC2026 highlights economic shift
    At the Alzheimer’s Association International Conference in London this year, the author observed that dementia now appears to have a clear business model, a shift from earlier meetings where commer…
    STAT · 14d agoPositive↗ source
  • Biotech confidence surges in 2026 as China leads growth and deal activity spikes
    Industry observers noted a marked shift in tone at two major 2026 biotech gatherings – the DIA China meeting in Shanghai and the BIO International Convention in San Diego – where participants expre…
    BioPharma Dive · 15d agoPositive↗ source
  • Bryan Johnson’s chronic disease is notoriously difficult to diagnose
    Why longevity entrepreneur Bryan Johnson’s chronic disease is notoriously difficult to diagnose.
    STAT · 1mo ago↗ source
  • Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal
    An arbitration panel ruled Prime didn’t breach a deal with Beam by developing a rare disease treatment. Elsewhere, European regulators are using a pancreatic cancer drug to test a new framework for…
    BioPharma Dive · 1mo ago↗ source
  • Opinion: STAT+: What’s the right role for AI in dementia care?
    Three tricky questions about using AI in dementia care.
    STAT · 1mo ago↗ source
  • Gene editing developer Scribe plots an IPO
    The California drugmaker, which has collaborations in place with Biogen, Sanofi and Eli Lilly, could be the 14th biotech to go public in 2026.
    BioPharma Dive · 1mo ago↗ source
  • Cancer, immune drugmakers dominate VC funding so far in 2026
    Drug developers focusing on either disease area made up more than 40% of the number of biotech companies and amount raised so far in 2026, per BioPharma Dive data.
    BioPharma Dive · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • Biogen adds more immune drugs in $1B buyout of secretive startup RayThera
    The companies didn’t specify the drugs Biogen is acquiring in the deal, though patents RayThera secured provide important clues.
    BioPharma Dive · 1mo ago↗ source
  • STAT+: FDA appears open to Moderna’s flu vaccine ahead of adcomm
    UniQure will submit Huntington's therapy for approval, Eli Lilly buys 4E Therapeutics, and more biotech news
    STAT · 1mo ago↗ source
  • STAT+: Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval
    The FDA has reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for its maker.
    STAT · 1mo ago↗ source
  • STAT+: A prominent VC explains why she’s against U.S. restrictions on investment in China’s drug industry
    Should the federal government try to slow — or even block — U.S. biotech deals that could benefit China?
    STAT · 1mo ago↗ source
  • The U.S. infant mortality rate fell to an all-time low, though it still trails other similar nations
    Infant mortality in the U.S. dropped to a new all-time low in 2025, according to CDC data, though it still trails other similar nations.
    STAT · 1mo ago↗ source
  • STAT+: ARCH-launched Neumora stops depression program
    A new AI model to improve trial enrollment, importing drugs from Canada, and more biotech news from The Readout
    STAT · 1mo ago↗ source
  • STAT+: Verge Labs’ new AI model solves patient stratification problems for neurology clinical trials
    As the saying goes, one man’s trash is another man’s treasure. Or as Verge Labs might put it, one company’s failed clinical trial … is that same company’s new AI…
    STAT · 1mo ago↗ source
  • Rapport ‘fully prepared’ to launch seizure drug solo, CEO says
    In a wide-ranging interview, Abe Ceesay detailed how Rapport built an investor syndicate and why the company is confident it can join the ranks of successful, commercial-stage brain drugmakers.
    BioPharma Dive · 2mo ago↗ source
  • Opinion: How long Covid’s scientific stalemate made it politically erasable
    Long Covid hasn’t disappeared. It’s just gone underground, writes Steven Phillips.
    STAT · 2mo ago↗ source
  • Sanofi stops immune drug trial in latest research setback
    The failure adds to a series of mixed or negative readouts and leaves in doubt the future of a therapy Sanofi has viewed as a potential blockbuster.
    BioPharma Dive · 2mo ago↗ source
  • Opinion: How the Amish think about vaccines, health care costs, and much more
    There may be nearly 2 million Amish Americans by 2075. That has large public health implications.
    STAT · 2mo ago↗ source