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  • Bayer's asundexian receives FDA approval for stroke prevention
    Bayer announced that the U.S. Food and Drug Administration has approved its oral anticoagulant asundexian for stroke prevention. The drug is indicated to lower the risk of subsequent stroke in pati…
    Endpoints · 9h agoApprovalPositive↗ source
  • BIO proposes seven-point plan to keep US biotech ahead of China
    BIO, a major biotech lobbying organization, released a seven‑part “BioAdvance” action plan aimed at preserving U.S. leadership in biotechnology as China rolls out its own five‑year strategy. The p…
    BioPharma Dive · 4h agoRegulatoryPositive↗ source
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  • London startup Oyster Therapeutics raises $60M to develop oral tau degraders for Alzheimer’s
    Oyster Therapeutics, a London‑based biotech, announced it has closed a $60 million Series A‑2 financing round. The round was led by 4BIO Capital, a life‑science venture capital firm, with addition…
    Endpoints · 2h agoDealPositive↗ source
  • London biotech Oyster raises $60 million to develop tau-targeting protein degraders
    Oyster Therapeutics, a London-based biotech, announced it has secured $60 million in an extension of its Series A financing round. The funding will support its lead program that uses a modified pr…
    BioPharma Dive · 2h agoDealPositive↗ source
  • Amneal and BridgeBio top BioSpace 2027 Best Places to Work list
    BioSpace released its 2027 Best Places to Work list, recognizing 50 life‑science employers with U.S. operations. Amneal Pharmaceuticals, based in Bridgewater, New Jersey, took the top spot among l…
    BioSpace · 4h agoPositive↗ source
  • FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High Risk
    FDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a rec…
    fda press · 11h agoApprovalPositive↗ source
  • Lilly's oral GLP-1 Foundayo cuts sleep apnea severity in Phase 3, paving way for second FDA filing
    Lilly said it will submit its oral GLP-1 drug Foundayo for FDA approval in obstructive sleep apnea after a late‑stage trial showed strong efficacy. The Phase 3 ATTAIN-OSA study enrolled about 712…
    BioSpace · 15h agoPositive readoutPositive↗ source
  • Argenx to acquire peptide specialist Unnatural Products in deal worth up to $1.15 billion
    Argenx announced it will purchase Unnatural Products, a peptide discovery biotech, in a transaction that could total up to $1.15 billion. The deal provides $550 million upfront, with additional co…
    BioSpace · 18h agoDealPositive↗ source
  • Bayer's Sunharbo receives FDA approval as first Factor XIa blood thinner
    FDA approved Bayer's new oral anticoagulant Sunharbo, marking the first U.S. approval of a Factor XIa inhibitor. The drug blocks Factor XIa, a protein that helps clots grow while playing a minor r…
    BioPharma Dive · 10h agoApprovalPositive↗ source
  • Novartis' Phase 3 HORIZON trial shows pelacarsen lowers Lp(a) but fails to cut cardiovascular events
    Novartis and Ionis reported that the Phase 3 HORIZON trial of the antisense drug pelacarsen did not improve major adverse cardiovascular events despite markedly lowering lipoprotein(a) levels. The…
    BioSpace · 17h agoNegative readoutNegative↗ source
  • Vir Biotechnology reports 44% undetectable hepatitis delta virus in Phase 3 trial, eyes mid-2027 filing
    Vir Biotechnology announced results from its Phase 3 Eclipse 1 trial of a monthly subcutaneous combination of siRNA therapy elebsiran and monoclonal antibody tobevibart for chronic hepatitis delta.…
    BioSpace · 15h agoPositive readoutPositive↗ source
  • Argenx to acquire Unnatural Products' macrocyclic peptide platform for $550 million upfront
    Argenx announced that it will acquire the California-based protein specialist Unnatural Products, paying $550 million upfront for its macrocyclic peptide platform. The deal could rise to more than…
    BioPharma Dive · 16h agoDealPositive↗ source
  • AbbVie and BMS each secure FDA approval, but impact of their neuro‑drug acquisitions remains uncertain
    AbbVie and Bristol Myers Squibb have both received FDA clearance for new Parkinson's treatments, prompting a fresh look at the large neuro‑focused deals they completed last year. AbbVie bought Cere…
    BioSpace · 1d agoDealNeutral↗ source
  • FDA launches Rare Disease Framework to embed patient input early in drug development
    FDA's Center for Biologics Research and Evaluation (CBER) director Karim Mikhail announced a new Rare Disease Framework Initiative aimed at moving patient perspectives from an optional, late‑stage…
    BioSpace · 1d agoRegulatoryPositive↗ source
  • India moves to suspend licenses of firms making substandard medicines
    The Indian government has proposed a rule that would immediately suspend the manufacturing licence of any company whose drug fails to meet quality standards. The initiative is intended to boost dr…
    raps · 1d agoRegulatoryNeutral↗ source
  • Third Rock Ventures commits up to $2.16 billion to AI-driven Chinese biotech Funnel Biosciences
    Third Rock Ventures disclosed a partnership with Chinese biotech Funnel Biosciences, committing up to $2.16 billion to support its AI-driven biologics platform. The agreement includes a research c…
    Endpoints · 14h agoDealPositive↗ source
  • FDA mandates label update for all GLP-1 drugs to warn of rare eye disease risk
    The FDA issued a class‑wide labeling requirement for all approved GLP‑1 receptor agonists, adding a warning about non‑arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that…
    BioSpace · 14h agoRegulatoryNeutral↗ source
  • Delix Therapeutics secures $100 million Series C to advance psychedelic pipeline
    Delix Therapeutics announced it has closed a $100 million Series C financing round. The capital will be used to accelerate development of its pipeline of psychedelic and neuroplastogen candidates…
    Endpoints · 17h agoDealPositive↗ source
  • Boehringer Ingelheim to seek approval for obesity injection survodutide after trial shows no added cardiovascular risk
    Boehringer Ingelheim announced it will file for regulatory approval of its investigational GLP-1 based obesity injection, survodutide, in the coming year. The move follows a phase 3 trial that dem…
    Endpoints · 17h agoApprovalNeutral↗ source
  • Compass Pathways to file FDA approval for psilocybin depression therapy within weeks
    Compass Pathways announced it will complete its FDA filing for the psilocybin‑based depression treatment COMP360 in the next two weeks. The company expects the rolling submission to enable a drug…
    BioSpace · 17h agoRegulatoryNeutral↗ source
  • J&J/Protagonist’s oral Icotyde shows Phase 3 benefit in psoriatic arthritis but trails AbbVie’s Skyrizi
    A Phase 3 study of Johnson & Johnson and Protagonist Therapeutics’ oral IL‑23 receptor antagonist Icotyde met its primary endpoint, demonstrating improvement in psoriatic arthritis symptoms. In th…
    BioSpace · 17h agoPositive readoutNeutral↗ source
  • Eli Lilly to pursue FDA approval for obesity drug in obstructive sleep apnea after positive Phase 3 trial
    Eli Lilly announced that it will seek regulatory approval for its obesity medication as a treatment for obstructive sleep apnea, following a successful Phase 3 study. The trial showed positive res…
    Endpoints · 18h agoPositive readoutPositive↗ source
  • Novo’s IL-6 inhibitor ziltivekimab may target milder cardio-renal patients after Phase 3 miss
    At the American Heart Association meeting, investigators discussed new data on Novo Nordisk’s IL-6 inhibitor ziltivekimab, suggesting it could be studied in patients with less severe cardiovascular…
    BioSpace · 19h agoNegative readoutNeutral↗ source
  • Marea Therapeutics' triglyceride drug lowers levels without raising blood sugar in high-risk patients
    Marea Therapeutics reported new data on its investigational lipid‑lowering medicine, showing it can further reduce triglyceride levels in patients with dangerously high blood concentrations. The s…
    Endpoints · 19h agoPositive readoutPositive↗ source
  • Argenx to acquire macrocycle biotech Unnatural Products in up to $1.15 billion deal
    Argenx announced Monday it will acquire Unnatural Products, a biotech focused on macrocycle therapeutics that began as a garage startup. The transaction is structured as an up-to-$1.15 billion dea…
    Endpoints · 22h agoDealNeutral↗ source