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761 stories matching this filter · ← front page

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  • Michael Ehlers joins Formation Bio to lead R&D; Black Diamond co-founder dies at 67
    Michael Ehlers left his CEO role at Ascidian Therapeutics, the exon editing company he co-founded, to run R&D at the AI biotech Formation Bio. It’s not often that biotech executives leave ...
    Endpoints · 2h ago↗ source
  • Sanofi nixes Kymab-originated OX40L antibody in atopic dermatitis
    Sanofi has decided to stop working on a drug for eczema it had hoped would be a successor to its immunological mega-blockbuster Dupixent. The French pharma said that it won’t seek ...
    Endpoints · 2h ago↗ source
  • Gene editor Scribe starts second-half IPO spree with $129M listing
    A 9-year-old biotech co-founded by CRISPR pioneer Jennifer Doudna is kicking off a run of biotech IPOs set for this year's second half. Scribe Therapeutics priced its $128.7 million
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Pulmonology5
Infectious Disease4
Ophthalmology3
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Endpoints · 11h ago
↗ source
  • FDA adcomm votes in favor of lifting restrictions on popular wellness peptide BPC-157
    An FDA advisory committee voted Thursday to recommend expanding access to a popular peptide used by health and wellness enthusiasts for repairing muscles and healing injuries. The recommendation se…
    Endpoints · 18h ago↗ source
  • FDA to end pilot aimed at preventing production issues
    The FDA said it will end a pilot that was intended to help drugmakers proactively address production issues. Few companies took advantage of the program during its three-year run. In April 2027,…
    Endpoints · 18h ago↗ source
  • Sartorius reduces revenue by €26M to refund Trump tariffs to customers
    Sartorius appears to be the first life science company to detail how tariff refunds are affecting its revenue, following the US Supreme Court decision to block some of President Donald Trump’s levi…
    Endpoints · 21h ago↗ source
  • Merck CEO cautions Congress on imposing limits on Chinese dealmaking
    Merck CEO Rob Davis said he has warned Congress and the Trump administration that if they cut off or hamper US-China dealmaking, the US could lose its status as the world's biotech leader. China-…
    Endpoints · 22h ago↗ source
  • Scancell plans Neuphoria merger; AstraZeneca wins EU nod for cancer drug
    Scancell to merge into Neuphoria: Scancell plans to take over Neuphoria Therapeutics' Nasdaq listing {$NEUP} and change the ticker to SCLT. The company eyes up to $89 million in equity and ...
    Endpoints · 22h ago↗ source
  • Biogen counts on drugs from Apellis deal to patch Leqembi's slow sales
    It’s no secret that sales of Leqembi have been disappointing. First approved in 2023, the Alzheimer’s drug from Eisai and Biogen launched shortly after Chris Viehbacher took the reins as Biogen C…
    Endpoints · 23h ago↗ source
  • What’s behind the proposed pullback on remote patient monitoring
    Companies that help doctors keep tabs on their patients at home are freaking out after Medicare's proposal last week to gut remote patient monitoring, or RPM. The plan is a total about-face from…
    Endpoints · 23h ago↗ source
  • Repligen’s $1.5B buy for BioLife; BeOne’s $300M US expansion
    Plus, news about Lonza, Bachem and Samsung Biologics. 🤝 Repligen to acquire BioLife Solutions: Repligen will pay around $1.5 billion for cell processing service supplier BioLife, 36% of which w…
    Endpoints · 1d ago↗ source
  • Lilly's triple agonist heads to regulators after two more Phase 3 obesity wins
    Retatrutide, the obesity candidate that has shown the most powerful weight loss in late-stage trials, will be filed for approval early next year, its developer Eli Lilly said Thursday. The filing…
    Endpoints · 1d ago↗ source
  • Roche says it is thoughtful on token use for AI, shelves a drug from Carmot buy
    Roche has offered some insight into how it is using AI, from drug discovery to token use. AI has already contributed to “a significant increase in new molecules” in its pipeline, CEO Thomas Schin…
    Endpoints · 1d ago↗ source
  • 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 · 1d 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…
    Endpoints · 1d ago↗ source
  • Recon: J&J nabs FDA authorization for general surgery robot; FDA urged to ban DTC drug ads
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 1d ago↗ source
  • Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studies
    <p>The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.</p>
    raps · 1d ago↗ source
  • Study: Most sponsors complete postmarketing trials, publish results
    <p>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…
    raps · 1d ago↗ source
  • FDA advisory committee backs two controversial peptides
    <p>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 woun…
    raps · 1d 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 · 1d 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 · 1d 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…
    Endpoints · 1d 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…
    Endpoints · 1d 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 · 1d 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 acquir…
    Endpoints · 1d ago↗ source