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1,694 stories matching this filter · ← front page

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  • FDA places Bright Minds seizure drug BMB-101 on partial hold over mouse toxicity, shares plunge
    The U.S. Food and Drug Administration issued a partial clinical hold on BMB-101, an experimental seizure treatment from Bright Minds Biosciences, after regulators identified toxicity concerns in pr…
    Endpoints · 7d agoRegulatoryNegative↗ source
  • AbbVie signs up to $757M deal with Beijing's Brise Pharma for two preclinical migraine candidates
    AbbVie announced a discovery and commercialization agreement with Brise Pharma, a Beijing-based biotech company. The partnership covers two preclinical migraine programs and is valued at up to $75…
    Endpoints · 6d agoDealNeutral↗ source
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  • Karyopharm Therapeutics to merge with Ayrmid as it enters bankruptcy
    Karyopharm Therapeutics, a commercial-stage biotech focused on blood cancers, announced it will pursue a merger with Ayrmid while navigating a bankruptcy process. The move aims to combine the two c…
    Endpoints · 7d agoDealNeutral↗ source
  • CinRx partners with Graviton Bioscience to target ROCK2 in pulmonary arterial hypertension and other cardiovascular diseases
    CinRx announced a collaboration with Graviton Bioscience, led by Sam Waksal, to develop therapies that inhibit the ROCK2 enzyme. The partnership will focus on pulmonary arterial hypertension (PAH)…
    Endpoints · 7d agoDealNeutral↗ source
  • Early Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+
    The dialyzer connector may not be attached appropriately, resulting in leaking and potential blood loss.
    fda medwatch · 7d agoRegulatoryNeutral↗ source
  • FDA warns against Once Upon a Farm Tractor Wheels toddler bars due to choking risk
    The U.S. Food and Drug Administration issued a consumer safety advisory concerning the organic toddler snack Once Upon a Farm Tractor Wheels. The agency cautioned that the soft‑baked bars pose a p…
    fda medwatch · 7d agoRegulatoryNegative↗ source
  • Halloween edition of Endpoints Weekly teases Anthropic biotech acquisition and Jake Van Naarden’s deal strategy
    The latest Endpoints Weekly arrives with a Halloween theme, offering a light‑hearted introduction to the issue’s content. Among the topics highlighted is Anthropic’s purchase of a one‑person biote…
    Endpoints · 9d agoNeutral↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 9d agoApprovalPositive↗ source
  • Aspen Neuroscience and Bambusa raise $310M combined in IPOs
    Aspen Neuroscience, a biotech focused on cell therapy for Parkinson's disease, announced it will raise about $141 million through its initial public offering scheduled for Friday. Bambusa, a start…
    Endpoints · 10d agoDealPositive↗ source
  • Instrumentation Laboratories recalls several lots of HemosIL AcuStar HIT-IgG(PF4-H) assay due to false-negative risk
    Instrumentation Laboratories (Werfen) has issued a recall of specific lots of its HemosIL AcuStar HIT-IgG(PF4-H) radioimmunoassay after the FDA identified a performance issue that could produce fal…
    fda medwatch · 10d agoCRLNegative↗ source
  • Sanofi plans to pursue higher European drug prices rather than delay product launches under Trump policy
    Sanofi indicated it may seek higher drug prices in Europe as part of a deal related to President Trump's pricing policies. Unlike other major European pharma companies that have warned the policie…
    Endpoints · 9d agoNeutral↗ source
  • Gilead places CAR-T program on partial hold after ICANS cases; Agios delays PDUFA submission
    Gilead announced a partial clinical hold on its CAR-T therapy after several patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). The hold will pause enrollment and…
    Endpoints · 9d agoRegulatoryNegative↗ source
  • AstraZeneca hints restructuring may trim R&D budget and move trials to emerging markets
    AstraZeneca's chief executive Pascal Soriot told journalists that the company's new restructuring program could lead to cost reductions in research and development and may see some clinical trials…
    Endpoints · 9d agoNegative↗ source
  • Sanofi says no major restructuring despite upcoming Dupixent patent expiration
    Sanofi's new chief executive, Belén Garijo, said after six months in charge that the company will not embark on a major overhaul of its business or research pipeline. The comment was made as the b…
    Endpoints · 10d agoNeutral↗ source
  • AstraZeneca launches $1.5 billion annual cost-saving plan to offset late-stage trial setbacks
    AstraZeneca announced a new cost‑saving initiative targeting $1.5 billion of annual expenses. The move follows a series of late‑stage clinical trial failures that have pressured the company's pipe…
    Endpoints · 10d agoNegative↗ source
  • Nova Biomedical issues safety instructions for StatStrip Glucose Hospital Meter Gen 2.0
    Nova Biomedical has sent a letter to customers using the StatStrip Glucose Hospital Meter System Gen 2.0, advising updated use instructions while a software fix is prepared. The FDA classified the…
    fda medwatch · 10d agoCRLNegative↗ source
  • Setara Biosciences raises $90 million to advance rare-disease pipeline after Actio spin-out
    Actio Biosciences shipped its precision epilepsy drug to Jazz Pharmaceuticals and then separated the rest of its genetics-driven pipeline into a new company called Setara Biosciences. Setara has s…
    Endpoints · 10d agoDealPositive↗ source
  • Anthropic appoints former Genentech scientist Nathan Frey to lead drug discovery after acquiring Coefficient Bio
    Anthropic, the AI company, recently bought biotech startup Coefficient Bio. Following the acquisition, the startup’s founder Nathan Frey, who previously worked at Genentech on machine‑learning proj…
    Endpoints · 10d agoNeutral↗ source
  • Former Be Bio chief Joanne Smith-Farrell appointed CEO of Orbis Medicines as Enanta CEO Jay Luly announces retirement
    Former Be Bio Pharmaceuticals CEO Joanne Smith-Farrell has joined Orbis Medicines as its new chief executive. Orbis, a startup backed by Eli Lilly and Novo Nordisk, focuses on developing oral macr…
    Endpoints · 10d agoNeutral↗ source
  • AI-Driven Biotech Startups May Soon Operate With Zero or One Employee, Says Endpoints News Live Discussion
    Endpoints News hosted an AI-focused event in New York, after which executive editor Drew Armstrong announced a live discussion titled "Is biotech's future full of zero and one employee startups?" s…
    Endpoints · 10d agoNeutral↗ source
  • Eli Lilly beats Q3 revenue forecasts, lifts full-year outlook
    Eli Lilly reported third-quarter revenue of $24.4 billion, roughly $2 billion above analysts' expectations. The outperformance underscores the company's strong position, driven in part by its GLP-…
    Endpoints · 11d agoEarningsPositive↗ source
  • Bristol Myers Squibb emphasizes pipeline strength and later-stage partnership focus amid patent cliff concerns
    Bristol Myers Squibb used its latest earnings call to outline how it plans to address an upcoming patent cliff that threatens revenue from several key products. Executives said the company is rely…
    Endpoints · 10d agoEarningsPositive↗ source
  • Merck R&D chief says company has outpaced rivals with its sac-TMT cancer platform
    Dean Li, the head of Merck Research Laboratories, said the company believes its sac-TMT cancer program gives it a competitive edge over other firms developing next-generation oncology therapies. T…
    Endpoints · 10d agoPositive↗ source
  • UK secures £500m biopharma investment as Vertex commits over £300m to new Oxford R&D hub, while Teva plans New Jersey plant closure
    The UK government’s autumn budget has attracted about £500 million in new biopharma commitments, signalling strong support for the sector. Vertex Pharmaceuticals disclosed that it will put more th…
    Endpoints · 11d agoDealNeutral↗ source
  • Ono Pharma’s endocannabinoid drug ONO-1110 fails five Phase 2 trials, prompting broader concerns
    Ono Pharma reported that its experimental endocannabinoid modulator ONO-1110 did not achieve the primary efficacy endpoint in five separate Phase 2 clinical trials. The failures span multiple indi…
    Endpoints · 11d agoNegative readoutNegative↗ source