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4,247 stories matching this filter · ← front page

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  • FDA approves generic lenacapavir for low-income markets; EMA to review Lundbeck's Deanxit over safety concerns
    The U.S. Food and Drug Administration has granted approval for a generic version of lenacapavir, a drug aimed at treating HIV, with the intention of making it available to lower-income countries.…
    raps · 8d agoApprovalNeutral↗ source
  • Midterm voters weigh health-care costs as urgent-care visits billed like ERs
    The upcoming midterm elections will see tens of millions of voters consider health‑care affordability, especially those whose coverage comes through their employers. The article points out that ri…
    STAT · 8d agoNegative↗ 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 · 8d agoDealNeutral↗ source
  • U.S. bioscience jobs up 7% from 2021 to 2025: Report
    Bioscience employment rose in 41 states, though not in California, according to a new report from the Biotechnology Innovation Organization and the Council of State Bioscience Associations.
    BioSpace · 8d agoRegulatoryNeutral↗ 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 · 8d 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 · 8d agoRegulatoryNeutral↗ source
  • Study finds patient agreement forms match knowledge surveys, urging greater transparency in FDA’s mifepristone REMS
    A randomized controlled trial published in JAMA Internal Medicine examined how well patients understood medication abortion when they signed the FDA’s risk evaluation and mitigation strategy (REMS)…
    raps · 8d agoRegulatoryNeutral↗ source
  • Study finds psilocybin does not produce lasting anxiety or depression relief in mice
    Five Bay Area laboratories joined forces to examine whether a single dose of psilocybin could produce lasting reductions in anxiety and depression-like behavior in mice. The study measured behavior…
    STAT · 8d agoNegative readoutNegative↗ source
  • Cancer can be treated safely during pregnancy, says maternal-fetal specialist
    Elyce Cardonick, a maternal-fetal medicine physician and founder of the Cancer and Pregnancy Registry, argues that pregnant cancer patients are often urged to terminate their pregnancies even thoug…
    STAT · 8d agoPositive↗ source
  • Australian regulator opens consultation on clinical trial data sharing and ICH GCP guidance
    The Therapeutic Goods Administration (TGA) in Australia has launched a public consultation seeking input on how clinical trial information should be shared under existing schemes. The consultation…
    raps · 8d agoRegulatoryNeutral↗ source
  • STAT calls for input on mitochondrial replacement therapy used in fertility tourism
    STAT is asking patients and clinicians to share their experiences with mitochondrial replacement techniques (MRT), sometimes called three-parent IVF, which are being marketed as a fertility option…
    STAT · 8d agoNeutral↗ 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 · 8d agoRegulatoryNegative↗ source
  • MedWatch Alert: FDA Advises Consumers Not to Buy or Serve Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked Bars
    Consumers Should Not Buy or Serve Once Upon a Farm Tractor Wheels, Organic Toddler Soft-Baked Bars Due to a Potentially Fatal Choking Hazard
    fda medwatch · 8d ago↗ source
  • Midterm election outcomes could reshape U.S. health policy, experts say
    The article notes that regardless of the results, the upcoming midterm elections will have broad effects on the U.S. health system, according to more than two dozen policymakers, lobbyists and expe…
    STAT · 10d agoRegulatoryNeutral↗ 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 · 10d 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 · 10d agoApprovalPositive↗ source
  • Regeneron posts $5.1 billion Q3 revenue, beating forecasts and highlighting strong sales of Dupixent, Eylea HD and Libtayo
    Regeneron reported third‑quarter revenue of $5.1 billion, well above the consensus range of $4.61‑$4.65 billion and representing a 36% increase from the same period last year. The company attribut…
    BioSpace · 11d agoEarningsPositive↗ source
  • AbbVie beats Q3 expectations, lifts full-year EPS outlook as immunology and neuroscience drive growth
    AbbVie reported third-quarter results that exceeded analysts' sales and earnings per share forecasts. The company posted $17.4 billion in revenue, driven largely by its immunology franchise which…
    BioSpace · 11d agoEarningsPositive↗ source
  • Alnylam shares tumble 25% as analysts flag uncertainties in its transthyretin franchise
    Alnylam Therapeutics saw its stock fall about a quarter on Thursday, closing near $174 after analysts highlighted a trio of uncertainties surrounding its transthyretin (TTR) franchise. The TTR fra…
    BioSpace · 11d agoEarningsNegative↗ source
  • Early-stage data show promise for targeting Wnt/β-catenin pathway across cancers
    Early-stage clinical results from the company and several peers indicate that the Wnt/β-catenin signaling pathway could become a viable target for treating a range of tumor types. The pathway has…
    BioSpace · 11d agoPositive readoutPositive↗ 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 · 11d 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 · 11d 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 · 11d 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 · 11d 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 · 11d agoNegative↗ source