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  • FDA warns Genzyme's Irish site over quality questions
    An FDA warning letter sent late last month to Genzyme's Ireland-based manufacturing site, now owned by Sanofi, raises significant quality- and data-related issues. On data integrity, the warning…
    Endpoints · 26d ago↗ source
  • WuXi AppTec seeks injunction over China military list
    WuXi AppTec has filed for a preliminary injunction to suspend its place on the Pentagon’s list of companies with alleged ties to the Chinese military. The injunction, dated June 29, seeks to stop…
    Endpoints · 26d ago↗ source
  • FDA approves Orca Bio’s cell therapy to improve transplant outcomes
    The FDA gave the go-ahead to Orca Bio’s T cell therapy that would reduce transplant-related complications for blood cancer patients. The therapy will be branded as Tregzi, an homage to the regula…
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Hematology6
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Endpoints · 26d ago
↗ source
  • BridgeBio gets funding for drug launch; United buys into cell therapy
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 26d ago↗ source
  • BridgeBio adds $1B as it prepares three more drug launches
    BridgeBio Pharma has reloaded with about $1 billion in a preferred equity deal to bolster its reserves ahead of three potential drug launches over the next year. The California biotech, which for…
    Endpoints · 26d ago↗ source
  • Ipsen to buy Swiss biotech Memo Therapeutics in potential $800M deal
    <figure><div><img src="https://imgproxy.divecdn.com/rFr9RThJC2782402VMoj7B8WOeODiV2bfIpEN0A2SvU/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS84LmpwZw==.webp"/></div></figure><p…
    BioPharma Dive · 26d ago↗ source
  • 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 · 26d 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 · 26d ago↗ source
  • 5 FDA decisions to watch in the third quarter of 2026
    <figure><div><img src="https://imgproxy.divecdn.com/ZralPibwV2FS7gfl92V7anvyG-GCm_2yJ_lZgP4LM4k/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS8yRENKUkI1LmpwZw==.webp"/></div></f…
    BioPharma Dive · 26d ago↗ source
  • Abivax shares surge as worries subside over immune drug’s cancer risk
    <figure><div><img src="https://imgproxy.divecdn.com/4eoVQHFTAvljHZA3dtwvKrrS1WlgcrV7_wLUFGcZYWw/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMjMwMTMxMDIyXzEua…
    BioPharma Dive · 26d 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 · 26d 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 · 26d ago↗ source
  • Ipsen’s $450M blood cancer drug; FDA selects first cohort for “pre-check” pilot program
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 26d 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 · 27d 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 announce…
    Endpoints · 27d 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 · 27d 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 · 27d 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 · 27d ago↗ source
  • Viridian may have edge over Amgen in eye drug showdown, analysts argue
    <figure><div><img src="https://imgproxy.divecdn.com/egbyTu8esim-VjYj5FTvMQUlBrndW-s35OSn02s-EoY/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMzk4NTE5MTYzLmpwZ…
    BioPharma Dive · 27d 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 Nola…
    Endpoints · 27d ago↗ source
  • These biotechs just landed big fundraising hauls. Here’s what they pitched to investors.
    <figure><div><img src="https://imgproxy.divecdn.com/gB0ZFwp5dREfmGbq6AMDBNj5FromoYE914x8tdybbBQ/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjIwMjU5MzY2LmpwZ…
    BioPharma Dive · 27d 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. Kuma…
    Endpoints · 27d 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: Th…
    Endpoints · 27d ago↗ source
  • Beeline ups its Series A round for immune drug work
    <figure><div><img src="https://imgproxy.divecdn.com/4FSYxYVR65mzzE0lNMMPQjdujTL0_B50-03lC1bSrS8/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS8yWEtHQ0JZLmpwZw==.webp"/></div></f…
    BioPharma Dive · 27d ago↗ source
  • Top FDA gene and cell therapy regulator to step down
    <figure><div><img src="https://imgproxy.divecdn.com/ZralPibwV2FS7gfl92V7anvyG-GCm_2yJ_lZgP4LM4k/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS8yRENKUkI1LmpwZw==.webp"/></div></f…
    BioPharma Dive · 27d ago↗ source