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1,145 stories matching this filter · ← front page

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  • 92Bio revives a T cell engager it had transferred to Amgen
    A small California startup is reviving an experimental T cell engager that its scientists originally developed but had handed off to Amgen years ago. After repeatedly saying it would bring the drug…
    Endpoints · 27d ago↗ source
  • Angitia ends Phase 3 in disc disease; Abivax targets $800M on colitis data
    🩻 Angitia Biopharmaceuticals drops Phase 3: The US and China biotech terminated a late-stage trial of AGA111 in patients with degenerative disc disease who had a lumbar interbody fusion, according…
    Endpoints · 27d ago↗ source
  • 5 FDA decisions to watch in the third quarter of 2026
    A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.
    BioPharma Dive
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· 27d ago
↗ source
  • Abivax shares surge as worries subside over immune drug’s cancer risk
    According to Abivax, fresh data suggest malignancy rates in its trials were no higher than "background" ones for people with ulcerative colitis, clearing a key safety concern.
    BioPharma Dive · 27d ago↗ source
  • Ipsen to scoop up Memo Therapeutics and its kidney infection drug
    Ipsen is on an M&A roll. The French drugmaker announced its second deal of the week, saying it would buy Memo Therapeutics and its drug candidate called potravitug for a viral ...
    Endpoints · 27d ago↗ source
  • A June flourish lifts biotech megaround tally in first half of 2026
    Forty private biotech companies disclosed funding rounds of $100 million or more in the first half of 2026, according to an Endpoints News tally. That's more than the same period of 2025 ...
    Endpoints · 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Sanofi’s Lumizyme successor passes Phase 3 test in babies with Pompe disease
    Sanofi said its enzyme replacement therapy succeeded in a registrational trial in a severe form of Pompe disease, paving the way for a key label expansion in the US. The French pharma is looking to…
    Endpoints · 28d ago↗ source
  • Beeline adds $126M to Bain-backed immunology pipeline from Bristol Myers
    Bristol Myers Squibb spinout Beeline Medicines is getting extra love from its existing backers and some of its management team. Bain Capital, the Canada Pension Plan Investment Board, and Bristol M…
    Endpoints · 28d ago↗ source
  • BeOne’s Brukinsa succeeds in frontline mantle cell lymphoma study
    BeOne Medicines said its BTK inhibitor Brukinsa cut the risk of disease progression or death by 43% compared to chemoimmunotherapy when used as a first option for mantle cell lymphoma patients. The…
    Endpoints · 28d ago↗ source