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890 stories matching this filter · ← front page

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  • Exclusive: Obesity biotech Verdiva hires ex-Metsera CMO as crucial readouts near
    Long-acting obesity pill developer Verdiva Bio has a new chief medical officer, and he comes from a biotech that was looking at very similar technology — and got bought for $10 billion not long ago…
    Endpoints · 6d ago↗ source
  • Teladoc is moving beyond its single-visit roots with new launch
    Over two decades ago, Teladoc built its business around quick doctor visits that didn't happen in person. Now, it's saying that the model of one-off virtual appointments is no longer enough. The te…
    Endpoints · 6d ago↗ source
  • Midwest Poultry Services. L.P. Recalls Shell Eggs Due to Possible Salmonella Enteritidis Contamination
    Midwest Poultry Services, L.P. is voluntarily recalling 1,589,577 dozen white shell eggs and brown cage free shell eggs produced in Texas because they have the potential to be contaminated with Sal…
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fda recalls · 6d ago↗ source
  • Recon: J&J nabs FDA authorization for general surgery robot; FDA urged to ban DTC drug ads
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 6d ago↗ source
  • Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studies
    The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.
    raps · 6d ago↗ source
  • Study: Most sponsors complete postmarketing trials, publish results
    Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the tim…
    raps · 6d ago↗ source
  • FDA advisory committee backs two controversial peptides
    An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for wound t…
    raps · 6d ago↗ source
  • Vertex was sole bidder in high-premium Crinetics acquisition
    Analysts expect new details on the lead-up to the deal “are likely to reignite” investor scrutiny that Vertex overpaid in what’s poised to be its largest-ever transaction.
    BioPharma Dive · 6d ago↗ source
  • GSK lung cancer drug gets speedy approval following $10.6B deal
    The clearance is GSK’s first for a lung cancer medicine and the latest step forward in a yearslong push by the British drugmaker into oncology.
    BioPharma Dive · 6d ago↗ source
  • FDA swiftly puts Makary era in the rearview mirror
    As the White House mulls a pick to lead the FDA, the Trump administration has been washing away the mark of former Commissioner Marty Makary, in a refresh that includes everything from reconsidered…
    Endpoints · 6d ago↗ source
  • Former FDA cancer chief Pazdur says the agency should restructure
    Richard Pazdur, who spent more than two decades leading the FDA’s cancer drug reviews, said the agency has a “golden opportunity” to restructure after being struck last year by the Trump administra…
    Endpoints · 6d ago↗ source
  • FDA approves Nuvalent's cancer drug, a week after GSK closed $10.6B buyout
    GSK's $10.6 billion acquisition of Nuvalent is delivering surprisingly early results. The FDA on Wednesday approved one of Nuvalent's lung cancer medicines two months earlier than projected, and th…
    Endpoints · 6d ago↗ source
  • Arrowhead hits ‘best-case scenario’ with latest results for fat-lowering drug
    To analysts, the drug’s apparent safety and effects on both triglyceride levels and pancreatitis cases should make it competitive with a rival Ionis therapy.
    BioPharma Dive · 6d ago↗ source
  • Arrowhead’s gene silencer competitive with Ionis’ in triglyceride disease
    Arrowhead Pharmaceuticals’ lipid-lowering drug has hit in two late-stage trials that could expand its use into a much wider population. Data shared Wednesday showed that Arrowhead’s gene silencer R…
    Endpoints · 6d ago↗ source
  • Trump threatens tariffs on imported generic drugs
    While the possibility of levies on branded pharmaceuticals have had a limited impact on drugmaker revenues, tariffs of up to 200% on copycat medicines could — depending on the specifics — prove mor…
    BioPharma Dive · 6d ago↗ source
  • Mentari adds $200M to migraine mission; Royalty's latest ATTR-CM deal
    Another $200M for Mentari: Migraine drug developer Mentari Therapeutics has lined up a second private placement as it works to close its reverse merger with InMed Pharmaceuticals. The Paragon Thera…
    Endpoints · 6d ago↗ source
  • Q&A: Lilly returns to neuropsych and looks ahead to Alzheimer's prevention
    LONDON — Eli Lilly, the world’s biggest drugmaker, appears to be getting more ambitious about tackling brain diseases. Last week, the company announced it would pay $2.8 billion upfront to acquire…
    Endpoints · 6d ago↗ source
  • Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
    A new analysis could address some doubts investors have had about ivonescimab, one analyst said. Elsewhere, Gilead and Merck debuted data for a once-weekly HIV tablet and a new pyschedelics competi…
    BioPharma Dive · 6d ago↗ source
  • Crystalys gets $130M to take Sobi-rivaling gout drug to market
    A San Diego biotech has raised an additional $130 million to get a gout drug that's already approved in Japan and China onto the US and European markets. Crystalys Therapeutics reeled in the Series…
    Endpoints · 7d ago↗ source
  • Crystalys nets $130M more to push gout drug through late-stage tests
    The startup has a broad global development program underway — and the support of more than 20 investment firms — for a treatment that’s approved in many Asian countries but isn’t yet available in t…
    BioPharma Dive · 7d ago↗ source
  • Summit reports two-year survival data for Western patients, though context lacking
    Summit Therapeutics unveiled additional follow-up data on its experimental cancer drug ivonescimab, and how its benefit compares between Asian and Western patients. But key context remains unknown.…
    Endpoints · 7d ago↗ source
  • Celldex scraps antibody in prurigo nodularis after Phase 2 flop
    Celldex said on Tuesday it will stop investigating its mast cell-targeting monoclonal antibody in a type of chronic itch disease after it failed on all efficacy measures in a mid-stage trial. Topli…
    Endpoints · 7d ago↗ source
  • Biopharma dealmaking in 2026: The recovery gathers speed in Q2
    It’s always darkest before the biotech dawn, and at no time was that more true than last summer, as biotech was experiencing a crisis of confidence. We tracked an industry-wide downturn in expectat…
    Endpoints · 7d ago↗ source
  • Vertex was only bidder for Crinetics in year's second-highest M&A premium
    To gain control of Crinetics Pharmaceuticals, Vertex Pharmaceuticals was willing to pay the second-highest premium so far in biopharma's banner year for M&A. And the Boston drugmaker was bidding ag…
    Endpoints · 7d ago↗ source
  • Trump pledges new tariffs on generic drugs not made in the US
    President Donald Trump on Tuesday evening said he will impose up to 200% tariffs on generic drugs sold in the US, if companies do not manufacture those medicines in America. Trump said that for the…
    Endpoints · 7d ago↗ source