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  • STAT+: AI company Anthropic announces it will begin developing drugs of its own
    AI giant Anthropic has already become a dominant player in technology and a household name for everyday users of artificial intelligence. Can it make drugs too?
    STAT · 27d ago↗ source
  • Ipsen’s $450M blood cancer drug; FDA selects first cohort for “pre-check” pilot program
    The planned acquisition of Kartos Therapeutics would hand Ipsen a late-stage asset for myelofibrosis. Elsewhere, Sobi hit a regulatory setback and BeOne unveiled more positive Brukinsa data.
    BioPharma Dive · 28d ago↗ source
  • Republican Tom Kean Jr. reveals depression diagnosis after his four-month absence from Congress
    Depression, the New Jersey congressman said, “is physical, it is emotional, and until you experience it yourself, it is difficult to fully understand how powerful this illness can be.”
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STAT · 28d ago
↗ source
  • FDA reviewers oppose allowing seven peptides for compounding
    Ahead of an FDA advisory committee meeting to discuss lifting restrictions on seven popular peptides, agency reviewers have recommended against including the peptides on a list of bulk drug substan…
    Endpoints · 28d ago↗ source
  • Anthropic debuts Claude Science, an AI product for bioscience
    Anthropic upended software programming with the runaway success of the coding agent Claude Code. For its next act, the AI lab is turning its attention to biopharma. On Tuesday, Anthropic announced…
    Endpoints · 28d ago↗ source
  • Eli Lilly, Fujifilm among seven selected for FDA’s PreCheck pilot
    The FDA has chosen the first seven companies to participate in its PreCheck pilot program, a group that includes large drugmakers Eli Lilly and Regeneron as well as manufacturers Cellares and Fujif…
    Endpoints · 28d ago↗ source
  • STAT+: Anthropic releases Claude Science, a product aimed at researchers, the pharma industry
    Anthropic released Claude Science, an application that optimizes its large language model for scientists and, especially, those doing research at pharma companies.
    STAT · 28d ago↗ source
  • AbbVie and Genmab's latest win brings Epkinly closer to label expansion
    AbbVie and Genmab’s bispecific antibody Epkinly succeeded in combination with a widely used cancer drug, bringing it one step closer to a potential label expansion in diffuse large B cell lymphoma.…
    Endpoints · 28d ago↗ source
  • Marburg outbreak is reported in Uganda, threatening to complicate Ebola response in region
    Sources confirm to STAT that Marburg cases have been detected in western Uganda, adding another viral hemorrhagic fever outbreak in central Africa.
    STAT · 28d ago↗ source
  • Abivax aims to set cancer concerns with ulcerative colitis drug to rest
    Late on Monday, Abivax released new trial data on its ulcerative colitis candidate, showing that cancer cases in a Phase 3 trial were within the expected range for these patients. The company says…
    Endpoints · 28d ago↗ source
  • Viridian may have edge over Amgen in eye drug showdown, analysts argue
    The FDA, through a new approval, gave Viridian's drug a label that some on Wall Street believe makes it well-positioned to compete against Tepezza in the thyroid eye disease market.
    BioPharma Dive · 28d ago↗ source
  • Health AI caution crosses into confidence
    How people in health tech feel about AI in healthcare has changed drastically from just a year ago. Each year, health tech venture firm Venrock partners Bob Kocher, Bryan Roberts and Siobhan Nolan…
    Endpoints · 28d ago↗ source
  • These biotechs just landed big fundraising hauls. Here’s what they pitched to investors.
    Biotechs aimed at eye diseases, autoimmune conditions and longevity medicine have pulled in some of the largest capital raises so far this year.
    BioPharma Dive · 28d ago↗ source
  • FDA's acting director of cell and gene therapies to leave position
    Vijay Kumar is leaving his role as acting director of CBER's Office of Therapeutic Products and will soon consider options both inside and outside the FDA, he told Endpoints News on Tuesday. Kumar…
    Endpoints · 28d ago↗ source
  • Sarepta's FDA decision date; Flare gets Anna Protopapas as CEO
    Plus news about Deerfield, InflaRx, Praxis, Nuvectis, Pyxis Oncology, Vistagen, Arcutis Biotherapeutics and Nxera. 🔎 FDA to decide on future of Sarepta exon-skipping drugs by end of February: The…
    Endpoints · 28d ago↗ source
  • Beeline ups its Series A round for immune drug work
    The company, which was built by Bain Capital, has now raised more than $426 million in its quest to advance a portfolio of Bristol Myers drugs.
    BioPharma Dive · 28d ago↗ source
  • STAT+: All of Us tests a new approach to collect real-world data for research
    The NIH All of Us Research Program has secured thousands of electronic medical records through an innovative use of patient data-sharing networks
    STAT · 28d ago↗ source
  • Top FDA gene and cell therapy regulator to step down
    Following Vijay Kumar’s exit, acting CBER Director Karim Mikhail will also oversee a review office that has become a battleground for debates on FDA flexibility.
    BioPharma Dive · 28d ago↗ source
  • STAT+: Investors double down on Bain-backed startup
    FDA's top gene therapy regulator steps down, Trump's plan to lower GLP-1 prices, and more biotech news
    STAT · 28d ago↗ source
  • STAT+: FDA digital leader hints at coming AI policy updates
    Today's health tech news includes virtual PT for a whole country, what the FDA is considering on AI policy, and more
    STAT · 28d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Chinese trial sites being probed, RFK Jr. and peptides, and more
    U.S. lawmakers are investigating whether several large drugmakers have been involved ​in clinical trials in China that helped fuel its military capability
    STAT · 28d ago↗ source
  • Nominations are open for the 2026 Endpoints 11 awards
    There’s never been a higher bar for innovation than right now. Almost any promising molecule quickly has a horde of copycats. Development costs keep rising. Investors are leaning on seemingly safer…
    Endpoints · 28d ago↗ source
  • How mental health chatbots are trained on therapy sessions
    As people increasingly turn to AI for everyday tasks, companionship and emotional assurance, virtual mental health companies once wary of AI are racing to build out their own chatbots to stay compe…
    Endpoints · 28d ago↗ source
  • Unicycive gets second CRL for kidney drug as manufacturing woes continue
    Unicycive Therapeutics’ chronic kidney disease drug was rejected by the FDA for a second time over persistent issues at a third-party contract manufacturer. The company’s phosphate binder drug oxyl…
    Endpoints · 28d ago↗ source
  • Half of states sue over Medicaid work requirements
    FDA peptide panelists, a new study on Covid and flu shots, and more health news from Morning Rounds
    STAT · 28d ago↗ source