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1,225 stories matching this filter · ← front page

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  • Artiva Biotherapeutics cuts 94% of workforce after patient deaths and failed autoimmune cell therapy
    Artiva Biotherapeutics announced it is halting development of its AlloNK natural killer cell therapy for autoimmune diseases and is laying off roughly 94% of its employees. The AlloNK product, an…
    Fierce Biotech · 16d agoLayoffsNegative↗ source
  • Labcorp acquires Millennium Health to expand toxicology testing nationwide
    Labcorp announced it is buying Millennium Health, a specialty laboratory that provides toxicology tests for recent use of prescription medications and illicit drugs. The acquisition is intended to…
    Fierce Biotech · 16d agoDealPositive↗ source
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  • FDA releases draft guidance on oversight of individualized gene-editing products
    The U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…
    raps · 16d agoRegulatoryNeutral↗ source
  • Aspen Neuroscience and Bambusa Therapeutics each target $134 million IPOs
    Aspen Neuroscience, a cell‑therapy company focused on Parkinson's disease, and Bambusa Therapeutics, a bispecific biotech, have filed SEC documents outlining plans for initial public offerings. Bo…
    Fierce Biotech · 16d agoDealNeutral↗ source
  • Leak of Moderna-Merck cancer vaccine phase 3 data sparks drama at ESMO 2026 conference
    The European Society for Medical Oncology (ESMO) meeting this year was marked by an unexpected leak of phase 3 results for a cancer vaccine being developed by Moderna and Merck. The data appeared t…
    Fierce Biotech · 16d agoNeutral↗ source
  • FDA issues early alert on B. Braun Streamline Bloodline Set recall due to connector leak risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert about B. Braun's Streamline Bloodline Set for Dialog+ after discovering a potential high risk issue. The problem is trace…
    fda medwatch · 16d agoCRLNegative↗ source
  • FDA approves prostate cancer and Crohn’s disease therapies as judge rejects effort to block Lilly weight‑loss ads
    The U.S. Food and Drug Administration announced approvals for new treatments targeting prostate cancer and Crohn’s disease. The decisions expand therapeutic options for patients with these conditio…
    raps · 16d agoRegulatoryNeutral↗ source
  • FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech Conference
    At the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests. They offered practical tips for companies seeking de novo designation, stressing…
    raps · 16d agoRegulatoryNeutral↗ source
  • Boehringer Ingelheim and Microsoft launch AI partnership to develop digital patient twins for clinical trials
    Boehringer Ingelheim and Microsoft announced a collaboration to investigate AI driven digital patient twins that model individual patients for clinical trial design. The work will explore disease…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Anthropic IPO filing reveals plans to build a drug discovery lab and pursue AI-driven therapeutics, noting scientific and regulatory hurdles
    Anthropic, known for its Claude AI platform, disclosed in its S-1 that it intends to expand into life-science research, including establishing its own molecular biology laboratory. The company aim…
    Fierce Biotech · 17d agoNeutral↗ source
  • Tango Therapeutics reports 82% response rate for PRMT5 inhibitor combo in pancreatic cancer trial
    Tango Therapeutics announced a 14% reduction in its workforce while also presenting new data on its PRMT5 inhibitor combined with Revolution Medicines’ RAS(ON) inhibitor Rasonque at the ESMO 2026 m…
    Fierce Biotech · 17d agoPositive readoutPositive↗ source
  • Bristol Myers Squibb partners with Institute for Healthcare Improvement to increase cancer trial participation
    Bristol Myers Squibb has entered a three-year collaboration with the Institute for Healthcare Improvement called the Cancer Collective Action Collaborative. The program will bring together 24 team…
    Fierce Biotech · 16d agoPositive↗ source
  • BioNTech's HER2-directed ADC shows modest benefit and higher lung toxicity in phase 3 trial
    BioNTech reported results of its phase 3 DYNASTY-Breast02 trial evaluating trastuzumab pamirtecan (t-pam), an HER2-directed antibody-drug conjugate, in patients with HR-positive, HER2-low metastati…
    Fierce Biotech · 17d agoNegative readoutNegative↗ source
  • FDA Commissioner Highlights New Rare Disease Framework Emphasizing Patient Voice
    Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas highlighted the agency's new rare disease framework during a fireside chat at the NORD Breakthrough Summit. The framework i…
    raps · 17d agoRegulatoryPositive↗ source
  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 17d agoApprovalNeutral↗ source
  • Corxel opts for SPAC merger to take oral obesity drug public on Nasdaq
    Corxel Pharmaceuticals, an obesity-focused biotech, said it will merge with Amanat Acquisition in the first half of next year to become a publicly traded company on Nasdaq. The company’s CFO noted…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Lycia Therapeutics raises $317.5 million in upsized Nasdaq IPO as Windward Bio eyes listing
    Lycia Therapeutics completed an initial public offering on Nasdaq, selling shares that generated roughly $317.5 million after the offering was upsized. The company’s debut on the exchange marks a…
    Fierce Biotech · 17d agoDealPositive↗ source
  • TGA opens consultation on temporary rise in Australian medical device annual fees
    The Therapeutic Goods Administration (TGA) in Australia announced a public consultation regarding a proposed temporary increase to the annual charges that medical device manufacturers must pay. Th…
    raps · 17d agoRegulatoryNeutral↗ source
  • Incyte reports strong early results for KRAS G12D inhibitor in pancreatic cancer, rivals RevMed
    Incyte presented phase 1 data at the European Society for Medical Oncology congress in Madrid, highlighting its KRAS G12D inhibitor INCB161734 combined with chemotherapy for pancreatic ductal adeno…
    Fierce Biotech · 18d agoPositive readoutPositive↗ source
  • J&J touts promising RIPTAC data with 59% PSA reductions in prostate cancer trial
    At the European Society for Medical Oncology (ESMO) 2026 meeting in Madrid, Johnson & Johnson presented early clinical data from its RIPTAC platform, which the company acquired through a $3 billion…
    Fierce Biotech · 18d agoPositive readoutPositive↗ source
  • ESMO: BMS’ Massacesi hails ‘very promising’ data for BioNTech-partnered PD-L1xVEGF-A drug
    Bristol Myers Squibb Chief Medical Officer Cristian Massacesi, M.D., has told Fierce that the latest data for its BioNTech-partnered PD-L1xVEGF-A drug are “very promising,” as phase 3 ambitions ram…
    Fierce Biotech · 18d agoNeutral↗ source
  • Roche reports superior survival for KRAS G12C inhibitor divarasib in phase 3 trial
    Roche presented detailed results from its phase 3 Krascendo 1 trial of the KRAS G12C inhibitor divarasib, comparing it with Amgen’s Lumakras and Bristol Myers Squibb’s Krazati. The open‑label stud…
    Fierce Biotech · 19d agoPositive readoutPositive↗ source
  • Merck and Moderna disclose phase 3 cancer vaccine data early after leak, showing improved recurrence-free survival with Keytruda
    Merck & Co. and Moderna were forced to release their phase 3 trial results for the intismeran autogene cancer vaccine two days ahead of schedule after an unexpected leak of the data ahead of the ES…
    Fierce Biotech · 19d agoPositive readoutNeutral↗ source
  • AstraZeneca says phase 3 ADC shows strong overall survival despite missing progression-free survival endpoint
    AstraZeneca executives emphasized that the detailed data from their phase 3 study of the next‑generation antibody‑drug conjugate are robust enough to be presented to regulators, even though the tri…
    Fierce Biotech · 19d agoPositive readoutNeutral↗ source
  • Genmab reports phase 3 success for Elahere competitor and previews Merus buyout data
    Genmab disclosed at the European Society for Medical Oncology meeting that its experimental therapy, positioned as a rival to Elahere, achieved a positive outcome in a phase 3 trial. The result si…
    Fierce Biotech · 19d agoPositive readoutPositive↗ source