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920 stories matching this filter · ← front page

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  • FDA proposes new rare disease framework to accelerate therapy development
    During a public hearing, FDA officials outlined a newly proposed rare disease framework aimed at creating a lasting regulatory scheme. The initiative seeks to speed the development of safe and eff…
    Fierce Biotech · 12d agoRegulatoryPositive↗ source
  • Biogen CEO says early-stage R&D now a priority after record five INDs this year
    Biogen's chief executive Chris Viehbacher told analysts that the company has shifted its strategy toward early-stage research and development. He highlighted that Biogen has filed five investigati…
    Fierce Biotech · 12d agoPositive↗ source
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  • Flagship launches Etcelera, an AI-driven biotech combining three platforms to predict drug effects
    Flagship Pioneering announced the formation of Etcelera, a new biotech emerging from stealth that will focus on AI-powered drug discovery. The company brings together the technologies of Cellarity…
    Fierce Biotech · 11d agoPositive↗ source
  • GSK says UK restructuring will have limited impact on staff, focusing cuts on support roles
    GSK executives said the company's global restructuring will only modestly affect UK staff, mainly targeting support functions at headquarters. CEO Luke Miels explained during the Q3 earnings call…
    Fierce Biotech · 12d agoLayoffsNegative↗ source
  • FDA issues draft guidance for electronic IDE submissions via eSTAR
    The U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Reso…
    raps · 12d agoRegulatoryNeutral↗ source
  • Novartis CEO keeps faith in Avidity deal despite taking $1.9B hit from del-desiran fail
    Novartis CEO Vas Narasimhan has insisted that the phase 3 fail for del-desiran is just a “bump” in the Swiss pharma’s wider plans for the drug, despite costing the company an estimated $1.9 billion.
    Fierce Biotech · 13d agoNegative readoutNegative↗ source
  • GSK's B7-H3 ADC cuts osteosarcoma progression risk by 67% in Chinese phase 3 trial
    A phase 3 study in China evaluated GSK's B7-H3‑directed antibody‑drug conjugate, risvutatug rezetecan (ris‑rez), in patients with relapsed osteosarcoma. The trial met its primary endpoint, showing…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • Syntax Bio claims four-day stem-cell conversion into pancreatic beta cells
    Chicago-based Syntax Bio says its Cellgorithm platform can turn stem cells into pancreatic beta cells in as little as four days. The company describes the process as a programmable set of epigeneti…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • 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 · 13d 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 · 13d agoDealPositive↗ source
  • 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 · 13d 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 · 13d 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 · 13d agoNeutral↗ 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 · 13d 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 · 13d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d agoRegulatoryNeutral↗ source