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1,129 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 · 5d 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 megablockbuster Dupixent. The French pharma said that it won’t seek ...
    Endpoints · 5d ago↗ source
  • Merck stages expanded access to monthly HIV PrEP pill ahead of approval
    Following in the footsteps of Gilead, Merck has signed voluntary licensing agreements to enable access to its investigational HIV PrEP pill alimatravir ahead of any regulatory submissions.
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Fierce Biotech · 5d ago
↗ source
  • Sanofi abandons plan to seek approval for eczema drug from $1.1B Kymab buyout
    Sanofi has abandoned plans to seek approval for amlitelimab in atopic dermatitis, admitting that a drug once tipped as a potential blockbuster “would not represent a meaningful improvement” to exis…
    Fierce Biotech · 5d ago↗ source
  • Gene editor Scribe starts second-half IPO spree with $129M listing
    A nine-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
    Endpoints · 5d ago↗ source
  • Scribe secures $129M in a rare gene editing IPO
    The startup is the first gene editing company to price an IPO in more than two years, though it banked far less than most other biotechs that have gone public in 2026.
    BioPharma Dive · 5d ago↗ source
  • Scribe records upsized $129M IPO to bankroll lipid-lowering genetic meds
    In vivo gene editing outfit Scribe Therapeutics has priced its IPO at $128.7 million, surpassing the $96 million goal set out earlier this week.
    Fierce Biotech · 5d ago↗ source
  • FDA panel endorses broader use of certain peptides
    In a victory for Robert F. Kennedy Jr.’s “MAHA” agenda, panelists narrowly recommended broader use of six of the seven peptides up for consideration despite a lack of substantive evidence supportin…
    BioPharma Dive · 5d ago↗ source
  • This Week at FDA: Diamantas touts onshoring efforts, grants for DHTs, and more
    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This we…
    raps · 5d ago↗ source
  • FDA advisory committee backs two more peptides, rejects one for compounding list
    By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was tasked…
    raps · 5d ago↗ source
  • Updated: FDA adcomm backs popular wellness peptides, despite staff concerns
    An FDA advisory committee voted to recommend expanding access to popular peptides used by health and wellness enthusiasts for repairing muscles, healing injuries, boosting metabolism and reducing i…
    Endpoints · 5d 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, th…
    Endpoints · 5d ago↗ source
  • Chutes & Ladders—Biogen R&D vet gets in Formation
    AI-focused Formation Bio has found a new chief scientist with extensive experience in biotech, Big Pharma and academia. Michael Ehlers, M.D., Ph.D., is joining the 2025 Fierce 15 honoree as chief s…
    Fierce Biotech · 5d 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 · 5d ago↗ source
  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health.
    BioPharma Dive · 5d 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-li…
    Endpoints · 5d 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 · 5d 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 CEO…
    Endpoints · 5d 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 th…
    Endpoints · 5d 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 will…
    Endpoints · 5d 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 h…
    Endpoints · 6d 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 Schinec…
    Endpoints · 6d 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 · 6d ago↗ source
  • Scancell to go public after winning reverse merger bid for troubled Neuphoria
    Scancell and Neuphoria have made their union official via a reverse merger that will result in a Nasdaq listing for Scancell and a resolution for Neuphoria’s shareholders after the biotech ended it…
    Fierce Biotech · 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