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668 stories matching this filter · ← front page

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  • How Butterfly, once known for its handheld ultrasound device, is growing its chip-making business
    Nvidia got its start as a gaming chip maker before meteoric success selling its chips to nearly every industry. One health tech company is hoping to go down a similar route. Last month, ultrasound…
    Endpoints · 28d ago↗ source
  • Roche’s KRAS G12C inhibitor beats rivals in head-to-head Phase 3 study
    Roche’s lung cancer drug candidate divarasib has beaten marketed drugs from Amgen and Bristol Myers Squibb in a head-to-head trial. Full data haven't yet emerged, but if the drug's survival benefit…
    Endpoints · 28d ago↗ source
  • Ex-iTeos CEO starts fresh at GSK neuro partner; Genentech loses yet another key scientist
    → Michel Detheux has succeeded Rita Balice-Gordon as CEO of Danish neuro biotech Muna Therapeutics, which is partnering with GSK on Alzheimer’s treatments. Balice-Gordon will slide over to ...
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fda recalls22
fda press21
fda medwatch17
Vaccines49
Hepatology44
Psychiatry & CNS37
Dermatology35
Pain33
Endpoints · 28d ago↗ source
  • BrightGene looks to the West as obesity shot nears China approval
    Armed with impressive Phase 3 data, BrightGene is taking its obesity shot to Chinese regulators. It expects trial data in the West to be even stronger, but its search for a partner for ex-China ter…
    Endpoints · 28d ago↗ source
  • Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
    Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
    fda medwatch · 28d ago↗ source
  • Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
    The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
    fda medwatch · 28d ago↗ source
  • FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
    The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recu…
    fda press · 29d ago↗ source
  • Merck scraps a Phase 2 Alzheimer's asset from partner Neuphoria
    Merck has axed a Phase 2 trial testing an experimental Alzheimer’s medicine, Endpoints News has learned. The company terminated a mid-stage test of the oral drug candidate MK-1167, a Merck spokespe…
    Endpoints · 29d ago↗ source
  • 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 le…
    Endpoints · 29d 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 t…
    Endpoints · 29d 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 regulato…
    Endpoints · 29d 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 y…
    Endpoints · 29d 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 · 29d 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 · 29d 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 · 29d 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 · 29d ago↗ source
  • FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
    The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult pat…
    fda press · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo ago↗ source