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3,182 stories matching this filter · ← front page

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  • Novartis' Zolgensma linked to tumors as FDA probes gene therapy and orders GLP-1 eye risk warnings
    Novartis confirmed that nine patients who received its Zolgensma gene therapy for spinal muscular atrophy have developed tumors, prompting the FDA to open an investigation into the approved treatme…
    BioSpace · 3h agoRegulatoryNegative↗ source
  • China’s five-year plan positions it to become a global leader in innovative biopharma by 2030
    China’s latest five‑year plan sets an ambitious target to turn the country into a major source of innovative medicines for the world market. Experts cited by BioSpace say the goal is within reach,…
    BioSpace · 8h agoRegulatoryPositive↗ source
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  • VectorY Therapeutics raises $83.5M Series A to develop brain-targeted antibody gene therapy
    VectorY Therapeutics announced it has closed a Series A financing round, adding €74.5 million ($83.5 million) to its capital. The funds will be used to advance its lead gene-therapy candidate VTx-…
    Endpoints · 1h agoDealNeutral↗ source
  • US biotech faces growth slowdown as China’s coordinated investment threatens industry
    During a BioSpace webinar, industry experts warned that uncertainty in U.S. policy is slowing biotech growth while China accelerates its life-science sector with deliberate investment. Strand Ther…
    BioSpace · 8h agoRegulatoryNegative↗ source
  • Merck KGaA receives FDA approval for Abbisko-licensed joint tumor therapy
    Merck KGaA announced that the U.S. Food and Drug Administration has granted approval to a drug it licensed from Chinese biotech Abbisko. The approval covers treatment of rare non-cancerous tumors t…
    Endpoints · 2h agoApprovalPositive↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 2h agoNeutral↗ 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 · 1h agoLayoffsNegative↗ source
  • UK science minister calls for more life sciences investment
    Now that the UK government has increased its spending on medicines, it’s calling for life sciences companies to do their part and invest on home soil. “We are determined to ensure that the UK is ...
    Endpoints · 32m ago↗ 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 · 23h 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 · 21h 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 · 23h agoPositive readoutPositive↗ source
  • 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 · 1d agoApprovalPositive↗ source
  • 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 · 19h agoRegulatoryNeutral↗ 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 · 1d agoRegulatoryPositive↗ source
  • Mirum readies FDA filing after positive Phase 3 results for hepatitis D therapy
    Mirum Pharmaceuticals announced that its hepatitis D candidate has met its primary goals in the second of two pivotal studies. The company said the data support moving the product toward regulatory…
    Endpoints · 18h agoPositive readoutPositive↗ source
  • Beam Therapeutics' base-edited sickle cell therapy shows success in Phase 1/2 trial
    Beam Therapeutics announced on Tuesday that its base-edited gene therapy for sickle cell disease met its primary endpoints in a Phase 1/2 study. The trial demonstrated that a single administration…
    Endpoints · 22h 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 · 22h agoLayoffsNegative↗ source
  • PepGen reports positive Phase 2 data for PGN-EDODM1 in myotonic dystrophy
    PepGen disclosed that its experimental oligonucleotide therapy PGN-EDODM1 showed encouraging early signals in a Phase 2 cohort of patients with myotonic dystrophy type 1 (DM1). The company said the…
    Endpoints · 22h agoPositive readoutPositive↗ source
  • 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 · 1d 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 · 1d agoDealPositive↗ source
  • Acting FDA commissioner reports strong public interest in new expedited IND pilot
    Acting FDA Commissioner Kyle Diamantas told attendees at the Friends of Cancer Research annual meeting that the agency’s newly launched Expedited IND pilot has attracted considerable public attenti…
    raps · 1d agoRegulatoryPositive↗ source
  • Democrats demand unredacted drug pricing agreements from pharma firms after midterm victories
    Congressional Democrats have intensified scrutiny of pharmaceutical pricing agreements made under the previous administration. On Monday they sent letters to every drug maker that entered a most f…
    Endpoints · 21h agoRegulatoryNeutral↗ 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 · 22h agoRegulatoryNeutral↗ source
  • White House pushes Heidi Overton nomination for FDA commissioner as confirmation window narrows
    The White House is actively promoting Heidi Overton's nomination to become the commissioner of the Food and Drug Administration. Administration officials are working to gather sufficient Senate su…
    Endpoints · 22h 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 · 1d agoRegulatoryNeutral↗ source