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  • Bayer's Sunharbo becomes first FDA-approved factor XIa inhibitor blood thinner
    Bayer's oral anticoagulant Sunharbo, known as asundexian, has received FDA approval, making it the first factor XIa inhibitor cleared for use in the United States. The drug is intended to lower th…
    BioSpace · 5h agoApprovalPositive↗ source
  • Beam Therapeutics' base-edited risto-cel shows 12-month pain-crisis freedom in sickle cell trial, paving way for FDA filing
    Beam Therapeutics reported that its base-edited cell therapy, risto-cel, achieved at least 12 consecutive months without severe vaso-occlusive crises in patients with sickle cell disease during a m…
    BioSpace · 5h agoPositive readoutPositive
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globenewswire health73
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Psychiatry & CNS1204
Ophthalmology1050
Endocrinology & Metabolism775
Pain775
Nephrology759
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  • FDA's new rare-disease framework faces first test with Capricor's Duchenne therapy decision
    The FDA announced a new "fit-for-purpose" rare disease framework that aims to evaluate therapies based on patient need and realistically attainable evidence. The first real test of the approach wi…
    BioSpace · 1h agoRegulatoryNeutral↗ source
  • AstraZeneca acquires Omniose to boost bacterial vaccine capabilities
    AstraZeneca has completed the purchase of Omniose, a specialist in vaccine bioconjugation, making the company a wholly owned subsidiary of its infectious disease division. The two firms began coll…
    Fierce Biotech · 10h agoDealPositive↗ source
  • Mirum's hepatitis D antibody brelovitug meets primary endpoint in phase 3 trial
    Mirum Pharmaceuticals announced that its experimental antiviral monoclonal antibody brelovitug achieved the primary efficacy goal in a phase 3 study for hepatitis D. The trial results continue a s…
    Fierce Biotech · 11h agoPositive readoutPositive↗ source
  • Coherus trims workforce by 30% as Gyre Therapeutics also cuts staff after acquisition
    Coherus Oncology announced a 30% reduction in its workforce as part of a reorganization that narrows its pipeline. The cuts follow a decision to deprioritize a combination therapy across multiple…
    BioSpace · 4h agoLayoffsNegative↗ source
  • PepGen's Phase 2 DM1 Data Show 46% Average Splicing Correction, Shares Jump 163%
    PepGen reported results from the 10 mg/kg multiple‑ascending‑dose cohort of its ongoing Phase 2 Freedom2‑DM1 trial, testing PGN‑EDODM1, an oligonucleotide designed to correct the molecular defect i…
    Fierce Biotech · 10h agoPositive readoutPositive↗ source
  • Intersurgical pulls 22mm smoothbore breathing tubes after FDA warns of detaching connectors
    The FDA Center for Devices and Radiological Health issued an early alert about a potentially high‑risk issue with certain Intersurgical breathing devices. Intersurgical has sent a letter to custom…
    fda medwatch · 15h agoRegulatoryNegative↗ source
  • FDA issues early alert as Arrow International recalls guidewires with spring wire guide components
    The FDA's Center for Devices and Radiological Health has issued an early alert about a potential high‑risk issue with certain Arrow International guidewire products that contain spring wire guide c…
    fda medwatch · 15h agoRegulatoryNeutral↗ source
  • Deerfield Management teams with AWS to boost AI-driven life-science ventures
    Deerfield Management announced a collaboration with Amazon Web Services aimed at accelerating AI-native healthcare and life-science companies in its portfolio. The agreement links AWS's generative…
    Fierce Biotech · 17h agoDealPositive↗ source
  • BIO urges US to create White House biotech office and streamline trials to stay ahead of China
    The Biotechnology Innovation Organization (BIO) released a seven-point "Bio Advance" plan aimed at strengthening the United States' biotech sector. The proposals call for easing the start-up of cli…
    BioSpace · 4h agoRegulatoryNeutral↗ source
  • Altimmune to discuss Phase 3 design for alcohol use disorder drug with FDA
    Altimmune is preparing to meet the FDA in December to discuss the design of a pivotal Phase 3 trial for its glucagon/GLP-1 dual receptor agonist pemvidutide. The Phase 2 RECLAIM study enrolled abo…
    BioSpace · 7h agoRegulatoryNeutral↗ source
  • AbCellera halts development of OX40 antibody ABCL575 after phase-1 trial
    AbCellera announced it will not move ABCL575 beyond phase 1, ending its OX40 program. The phase-1 study met its endpoints, showing a favorable tolerability profile and pharmacokinetics that suppor…
    Fierce Biotech · 15h agoNegative↗ source
  • Coherus Oncology cuts 30% of staff to focus on esophageal cancer combo
    Coherus Oncology announced another round of layoffs, reducing its workforce by about 30% as it narrows its development program. The cuts follow the presentation of phase 1b data on a combination o…
    Fierce Biotech · 16h agoLayoffsNeutral↗ source
  • Novocure's Optune Mya device denied FDA approval over efficacy concerns
    Novocure received a "not approvable" letter from the FDA for its Optune Mya system, which was being evaluated for patients with brain metastases from non‑small cell lung cancer after stereotactic r…
    Fierce Biotech · 17h agoRegulatoryNegative↗ source
  • Delix raises $100M to advance at-home psychedelic without hallucinatory effects
    The series C raise, co-led by Johnson & Johnson’s venture capital arm, will help Delix Therapeutics push its novel psychedelic asset into mid-stage development for major depressive disorder.
    BioSpace · 6h agoRegulatoryNeutral↗ 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 · 15h agoPositive↗ source
  • Delix raises $100M to advance at-home psychedelic without hallucinogenic effects
    The series C raise, co-led by Johnson & Johnson’s venture capital arm, will help Delix Therapeutics push its novel psychedelic asset into mid-stage development for major depressive disorder.
    BioSpace · 6h ago↗ 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 · 22h 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 · 1d 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 · 1d agoDealPositive↗ 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 · 1d 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 · 1d agoPositive readoutPositive↗ source
  • Delix Therapeutics raises $100M Series C to advance non-hallucinatory psychedelic for depression
    Delix Therapeutics announced a $100 million Series C financing round, led by Johnson & Johnson’s venture arm JJDC and joined by investors such as SV Health Investors’ Dementia Discovery Fund, RA Ca…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Windward Bio targets $204M Nasdaq IPO to fund Chinese respiratory drug program
    Windward Bio, a biotech backed by Sanofi, announced plans to go public on Nasdaq with an offering of 10.3 million shares priced between $16 and $18 each. The company expects net proceeds of about $…
    Fierce Biotech · 1d agoDealNeutral↗ source