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393 stories matching this filter · ← front page

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  • Novo files US and EU approval for etavopivat, its $1B acquired sickle-cell therapy
    Novo submitted regulatory applications in the United States and Europe for etavopivat, a sickle cell disease therapy it bought from Forma Therapeutics in a $1 billion transaction. The company says…
    BioPharma Dive · 5h agoApprovalPositive↗ source
  • Swiss biotech Windward Bio raises $175 million in IPO to fund lung-drug development and test Tezspire competitor
    Windward Bio, a Swiss immune‑drug developer, completed a $175 million initial public offering, selling about 10.3 million shares at $17 each. The company began trading on the exchange under the tic…
    BioPharma Dive · 19h agoDealPositive↗ source
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114
fda medwatch112
globenewswire health73
fda press59
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Psychiatry & CNS1221
Ophthalmology1079
Endocrinology & Metabolism785
Pain784
Nephrology764
  • Arrowhead faces challenges as Ionis's Tryngolza sales fall short, putting sHTG launch at risk
    Ionis Pharmaceuticals reported flat sales of its severe hypertriglyceridemia drug Tryngolza, generating only $9 million and cutting its annual revenue outlook to $50 million. The weak performance…
    BioSpace · 4h agoEarningsNegative↗ source
  • Regeneron's POTS antibody shows heart-rate reduction in Phase 2, paving way for Phase 3 trial
    Regeneron reported results from its Phase 2 Pinnacle trial of a monoclonal antibody targeting postural orthostatic tachycardia syndrome (POTS), a disorder with no approved therapies. The trial enr…
    BioSpace · 6h agoPositive readoutPositive↗ 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 · 3h agoLayoffsNegative↗ source
  • Pfizer secures up to $1.5 billion from Blackstone to fund berobenatide obesity drug development
    Pfizer announced a financing arrangement with Blackstone Life Sciences that could provide up to $1.5 billion to support the development of berobenatide, an obesity drug acquired from Metsera. The…
    BioSpace · 1d agoDealPositive↗ source
  • Eros Apothecary recalls Candy Power For Man honey supplement after undisclosed tadalafil found
    Eros Apothecary of Indio, California announced a recall of its Candy Power For Man Organic Honey dietary supplement after FDA testing revealed the presence of undeclared tadalafil. Tadalafil is th…
    fda recalls · 1d agoCRLNegative↗ source
  • BMS to consolidate R&D under single leader as chief research officer exits
    Bristol Myers Squibb announced a reorganization of its research and development unit, merging early research and discovery with drug development under a single leader. Chief Research Officer Rober…
    BioSpace · 1d agoNeutral↗ source
  • Game Changer Products recalls 10 Day Forecast capsules after FDA finds undeclared sildenafil and acetaminophen
    Game Changer Products LLC announced a voluntary nationwide recall of its 10 Day Forecast capsules, a dietary supplement marketed at 3200 mg. The FDA’s analysis detected the presence of undeclared…
    fda recalls · 1d agoCRLNegative↗ source
  • PepGen stock surges as DM1 oligonucleotide PGN-EDODM1 shows record splicing correction in Phase 2
    PepGen reported that its experimental oligonucleotide PGN-EDODM1 achieved a mean splicing correction of 46.5% at week 13 in a Phase 2 trial for myotonic dystrophy type 1 (DM1). This performance exc…
    BioSpace · 2d agoPositive readoutPositive↗ source
  • 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 · 3d 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 · 3d agoPositive readoutNegative↗ 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 · 3d 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 · 3d agoLayoffsNegative↗ 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 · 3d 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 · 4d agoPositive readoutPositive↗ 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 · 4d 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 · 4d agoPositive readoutNeutral↗ 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 · 7d agoLayoffsNegative↗ source
  • Eugia US recalls specific lot of vancomycin injection after glass particle found in vials
    Eugia US LLC, formerly Auro Medics Pharma, announced a voluntary nationwide recall of the vancomycin hydrochloride injection (1.25 g per 30 mL vial) for lot number 3VM26026A. The recall was trigge…
    fda recalls · 7d agoCRLNegative↗ 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 · 8d 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 · 8d 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 · 8d agoDealPositive↗ source
  • Alethio Therapeutics raises $90 million Series A to develop antibody for essential thrombocythemia
    Alethio Therapeutics, a spinout from the University of Oxford, announced a $90 million Series A financing round. The capital will fund the company’s lead program, an antibody designed to treat ess…
    Endpoints · 8d 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 · 8d agoDealPositive↗ source