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358 stories matching this filter · ← front page

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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 · 8h agoApprovalPositive↗ source
  • Beam Therapeutics reports successful pivotal trial of base editing sickle cell therapy
    Beam Therapeutics announced that its base editing treatment, ristoglogene autogetemcel (risto‑cel), met its primary goal in a pivotal trial for sickle cell disease. The trial showed the therapy cou…
    BioPharma Dive · 6h agoPositive readoutNegative↗ source
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  • 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 · 7h 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 · 7h agoLayoffsNegative↗ 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 · 1d agoApprovalPositive↗ 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 · 1d agoApprovalPositive↗ 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
  • Phase 3 trial shows Zealand-Boehringer obesity drug survodutide does not raise cardiovascular death risk
    The Phase 3 SYNCHRONIZE-CVOT study found that survodutide, the joint obesity therapy from Zealand and Boehringer Ingelheim, was non‑inferior to placebo for cardiovascular death, indicating no added…
    BioSpace · 1d agoPositive readoutNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 1d agoLayoffsNegative↗ source
  • Agios cuts over 35% of R&D staff as FDA decision on sickle cell drug is delayed
    Agios announced it will eliminate more than 100 R&D positions, representing over a third of its research staff, after the FDA postponed a decision on its sickle cell disease candidate. The company…
    BioSpace · 4d agoLayoffsNegative↗ source
  • J&J and AbbVie present early trispecific antibody data for multiple myeloma at ASH meeting
    At the American Society of Hematology (ASH) meeting, Johnson & Johnson and AbbVie are slated to share early clinical data on trispecific antibodies targeting multiple myeloma. These next‑generation…
    BioPharma Dive · 5d agoPositive readoutPositive↗ source
  • British biotech T-Therapeutics raises $133 million Series B to advance bispecific T-cell engagers
    T-Therapeutics, a British biotech, announced a $133 million Series B financing to advance its next-generation T-cell engager therapeutics. The round was co-led by Advent Life Sciences and the Brit…
    BioSpace · 5d agoDealPositive↗ source
  • T-Therapeutics secures $133 million Series B to advance bispecific cancer and autoimmune drugs
    T-Therapeutics, a UK-based biotech focused on T-cell engager technology, announced a $133 million Series B financing. The capital will be used to generate proof-of-concept data for its lead bispec…
    BioPharma Dive · 5d agoDealPositive↗ source
  • Alethio Therapeutics secures $90 million to develop treatments for rare blood cancers
    Alethio Therapeutics, a UK based biotechnology startup, announced it has raised $90 million in new financing. The capital will be used to advance its pipeline targeting myeloproliferative neoplasm…
    BioPharma Dive · 5d agoDealPositive↗ source
  • Novo claims 80% share of oral GLP-1 market as rivalry with Lilly intensifies
    Novo's CEO Mike Maziar Doustdar said the company leads the oral GLP-1 market, stating the Wegovy pill holds about 80% of prescriptions since its launch in January. Eli Lilly, however, reported tha…
    BioSpace · 6d agoEarningsNeutral↗ source
  • Novartis ends $772M BioArctic brain-delivery partnership
    Novartis has terminated its neurodegeneration alliance with BioArctic, a partnership that was valued at more than $772 million. The collaboration focused on using BioArctic’s BrainTransporter techn…
    BioSpace · 7d agoDealNegative↗ source
  • Cell and gene therapy funding climbs to $2.2 billion in Q3 despite safety setbacks in CAR-T trials
    Sail Biomedicine’s $925 million agreement with Johnson & Johnson helped lift venture capital money into the cell and gene therapy (CGT) space during the third quarter. CGT attracted $2.2 billion a…
    BioSpace · 8d agoDealNeutral↗ source
  • Karyopharm files for Chapter 11 and plans auction with Gamida Cell parent Ayrmid as lead bidder
    Karyopharm Therapeutics, a cash-strapped cancer drugmaker, announced a Chapter 11 filing on Monday and will conduct a court-supervised auction of the company. Ayrmid, the parent of cell-therapy co…
    BioPharma Dive · 8d agoDealNegative↗ source
  • AstraZeneca outlines restructuring as earnings show cost cuts, while Alnylam slides and Regeneron posts record quarter
    AstraZeneca said it will redeploy resources through a new restructuring program aimed at cutting costs while staying on track to hit its long‑term revenue goal of $80 billion by 2030. The company h…
    BioPharma Dive · 8d agoEarningsNeutral↗ source
  • Karyopharm files for Chapter 11 bankruptcy as it pursues merger with Ayrmid
    Karyopharm Therapeutics has filed for Chapter 11 bankruptcy while seeking a merger with U.K. biotech Ayrmid. The court‑supervised process is intended to provide a financial lifeline for the company…
    BioSpace · 8d agoNegative↗ source
  • Top pharma firms line up for Summit Therapeutics' ivonescimab after strong China Phase 3 data
    Several major biopharma companies, including AstraZeneca, Pfizer and Revolution Medicines, are expressing strong interest in Summit Therapeutics' Akeso-partnered bispecific antibody ivonescimab. Th…
    BioSpace · 8d agoDealPositive↗ source
  • BridgeBio eyes first FDA approval for limb-girdle muscular dystrophy therapy
    BridgeBio Pharma is preparing for a potential launch of its experimental drug BBP-418 aimed at treating limb-girdle muscular dystrophy type 2I/R9, pending FDA decision. The agency has set a review…
    BioSpace · 8d agoRegulatoryPositive↗ 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 · 11d agoApprovalPositive↗ source
  • Acumen scraps sole asset after Alzheimer’s fail, plunging stock 80%
    Acumen will implement cash-saving strategies and assess its options after sabirnetug failed to beat placebo, leaving the biotech without a clinical program.
    BioSpace · 11d agoRegulatoryNeutral↗ source
  • Genmab shares jump as petosemtamab plus Keytruda halves death risk in head-neck cancer trial
    Genmab reported that a late-stage study of its experimental antibody petosemtamab combined with Keytruda cut the risk of death by about 50 percent compared with Keytruda alone in patients with PD‑L…
    BioPharma Dive · 12d agoPositive readoutPositive↗ source