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2,490 stories matching this filter · ← front page

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  • Astellas commits up to $285M upfront for Audax's preclinical IL-12 program, with potential $1.05B milestones
    Astellas Pharma has entered a licensing agreement with Audax Biosciences to gain rights to the latter’s IL-12 immuno‑oncology candidate DAX‑044. Under the deal, Astellas will pay up to $285 millio…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Geron halts phase 3 Rytelo trial after data monitoring panel deems unlikely to improve survival in JAK-inhibitor-pretreated myelofibrosis
    Geron announced the discontinuation of its phase 3 IMpactMF trial of Rytelo (imetelstat) in patients with myelofibrosis who had previously failed JAK inhibitor therapy. The decision followed an in…
    Fierce Biotech · 11d agoNegative readoutNegative
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↗ source
  • FDA drafts guidance to speed approvals of individualized gene therapies, hailed as win for rare disease patients
    The U.S. Food and Drug Administration released draft guidance aimed at streamlining the approval process for certain individualized gene therapies. The proposal would allow sponsors to avoid filing…
    STAT · 11d agoRegulatoryNeutral↗ source
  • Oura and UC San Diego Health launch trial linking smart ring data to obesity treatment outcomes
    Oura and UC San Diego Health have partnered on a multi-year clinical trial called SMART-BMI to explore how continuous data from the Oura Ring may reflect patient response to obesity therapies. The…
    Fierce Biotech · 11d agoPositive↗ source
  • 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 · 11d 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
  • Epic's data‑blocking tactics curb health‑tech innovation, investigation finds
    A STAT investigation reveals that Epic Systems, the leading electronic health record vendor, is deliberately limiting access to patient data for competing software developers. This practice gives E…
    STAT · 12d agoNegative↗ source
  • 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
  • HHS adopts temporary policy to let compounding pharmacies produce six unapproved peptides
    HHS announced a temporary policy that grants enforcement discretion to state-licensed compounding pharmacies, federal facilities, and licensed physicians who compound six specific peptide products…
    STAT · 11d agoRegulatoryNeutral↗ 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
  • Lawmaker asks GAO to examine TrumpRx claims of $700 million drug savings
    Representative Frank Pallone, the ranking member of the House Energy and Commerce Committee, sent a letter to the Government Accountability Office asking it to assess whether the TrumpRx website ha…
    STAT · 11d agoRegulatoryNegative↗ source
  • Epic’s dominance forces health-care AI firms to adapt, new STAT+ analysis finds
    The latest STAT+ AI Prognosis newsletter examines how Epic’s entrenched position in electronic health-record systems is shaping the strategies of health-care artificial-intelligence companies. The…
    STAT · 11d agoNeutral↗ source
  • U.S. overdose deaths fell 27% in 2024, with early 2025 data showing further decline
    U.S. overdose mortality dropped 27% in 2024 after years of steep increases, and preliminary figures for 2025 suggest the trend is continuing, though the overall death rate remains high. A Health a…
    STAT · 12d agoPositive↗ source
  • Pediatricians work to calm families and promote MMR vaccination amid Pennsylvania measles outbreak
    A pediatrician at the Children’s Hospital of Philadelphia describes a growing measles outbreak in Pennsylvania, noting more than 1,300 reported cases with roughly a third affecting children. Paren…
    STAT · 12d agoNeutral↗ source
  • Michigan Senate candidate Abdul El-Sayed vows to challenge RFK Jr. and push Medicare for All
    Abdul El‑Sayed, a Michigan Democrat and former public‑health official, is nearing the end of a contentious Senate campaign. He has announced he will aggressively question Robert F. Kennedy Jr., lab…
    STAT · 11d agoNeutral↗ source
  • Physician's personal egg-freezing story highlights systemic sexism in fertility industry
    In an opinion piece, NYU assistant professor Pooja Yerramilli reflects on her own egg-freezing experience after Democratic Representative Alexandria Ocasio-Cortez sparked a national conversation ab…
    STAT · 12d agoNegative↗ source
  • STAT seeks input on how Epic's practices affect hospital technology choices
    Epic is the largest electronic health records vendor in the United States, with its systems used by most large health systems and covering the health data of roughly eight in ten Americans. Indust…
    STAT · 12d agoNeutral↗ source
  • STAT+: Lilly’s triple-G drug beats Ozempic in head-to-head study
    Eli Lilly announced that its investigational drug retatrutide was more effective at lowering blood sugar and cutting weight than Novo Nordisk’s Ozempic in a large diabetes study.
    STAT · 11d ago↗ source
  • Phase 3 trial shows cancer vaccine intismeran autogene cuts recurrence risk by 42% versus Keytruda
    At the European Society for Medical Oncology Congress, a Phase 3 trial of the personalized cancer vaccine intismeran autogene reported a 42% reduction in risk of recurrence or death compared with p…
    STAT · 13d agoPositive readoutPositive↗ 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 · 12d 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 details on accelerated approval process for personalized gene therapies
    The U.S. Food and Drug Administration has issued additional guidance on a faster approval pathway designed for personalized gene therapies. The new details outline how sponsors can seek expedited r…
    STAT · 12d agoRegulatoryPositive↗ source