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1,042 stories matching this filter · ← front page

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  • Amgen shares new Tavneos analysis in effort to resolve FDA dispute
    Amgen shared a new analysis with the FDA that the company said supports keeping its controversial rare disease drug Tavneos on the market. The submission, made Thursday, includes an independent r…
    Endpoints · 55m ago↗ source
  • Sanofi halts development of troubled immune drug in eczema
    <figure><div><img src="https://imgproxy.divecdn.com/FBR1IQNmU9Hqatva496Zg2G8JMHsqV0UGsf4LMARqYo/g:nowe:189:144/c:1776:1003/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS80OTY5MDc4Mzc…
    BioPharma Dive · 3h ago↗ source
  • Ipsen’s Bylvay fails key trial in children with rare liver disease
    Ipsen disclosed that Bylvay failed a Phase 3 study for biliary atresia, a serious liver disease that leads the bile ducts to become blocked in babies. Babies with the disease can get a Kasai proc…
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Hematology6
Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
Endpoints · 3h ago
↗ source
  • Biogen’s Alzheimer’s data spur excitement, confusion about tau-targeting drugs
    LONDON — One of the most anticipated Alzheimer’s studies in the past few years has created both enthusiasm and confusion, according to conversations Endpoints News recently had with about 20 scient…
    Endpoints · 4h ago↗ source
  • Novo asks court to block Lilly ads; Merck strikes HIV PrEP deal
    Plus news about Abbvie and Genmab, Johnson & Johnson and Mannkind. Novo urges court to block Lilly’s GLP-1 ads: Novo Nordisk asked a New Jersey federal court on Friday to temporarily block wh…
    Endpoints · 4h ago↗ source
  • CHMP recommends Minoryx’s ALD drug, rejects Zevra’s Meplyffa
    Minoryx Therapeutics finally scored backing from EU regulators for its neurological drug that’s faced multiple hurdles. Meanwhile, Zevra’s rare disease drug got a setback in Europe almost two years…
    Endpoints · 5h ago↗ source
  • Novo escalates legal fight with Lilly; J&J reinforces ‘dominance’ in multiple myeloma
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 6h ago↗ source
  • Study of Yescarta patients reveals genetic red flags for CAR-T therapy side effects
    A new analysis of patients who took part in clinical trials for Kite Pharma’s CAR-T cell therapy Yescarta has revealed genetic signatures of toxicity risk, potentially providing a path forward for…
    Fierce Biotech · 6h ago↗ source
  • 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 · 8h 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 · 8h 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.
    Fierce Biotech · 9h 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 · 13h 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 · 17h ago↗ source
  • Scribe secures $129M in a rare gene editing IPO
    <figure><div><img src="https://imgproxy.divecdn.com/v0D5Ajbuzjf7G4SQRuR5yVFGXoGWXxkevKZwUQRcJjs/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMTU2MTc2MTM5LmpwZ…
    BioPharma Dive · 17h 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 · 18h ago↗ source
  • FDA panel endorses broader use of certain peptides
    <figure><div><img src="https://imgproxy.divecdn.com/d2JyuXgmLsPVrlZlLVlPLECICsiII5W1r34tQBQf49c/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjI3NzEwNTIwX0w2O…
    BioPharma Dive · 18h 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 · 1d 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 · 1d 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 · 1d 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 · 1d ago↗ source
  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    <figure><div><img src="https://imgproxy.divecdn.com/x5fF_ZCHHBjPFAGFuuKXSVkAgBGYTo2hZBIz9OcQdEo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMDkyNDczMjEzLmpwZ…
    BioPharma Dive · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d ago↗ source