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1,622 stories matching this filter · ← front page

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  • 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 · 13d agoPositive↗ source
  • FDA releases draft guidance to streamline approval of personalized gene therapies
    The FDA announced a draft guidance aimed at expanding access to gene therapies that target different mutations within the same disease. The proposal outlines an "individualized feature space" that…
    BioPharma Dive · 13d agoRegulatoryPositive↗ source
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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 · 13d agoRegulatoryPositive↗ source
  • Eli Lilly to merge U.S. and international units after exec retirement; Novartis records $1.9B impairment on failed Avidity drug
    Eli Lilly announced that its U.S. and international divisions will be combined into a single unit called "Lilly Global Markets" after the retirement of long‑time executive Patrik Jonsson at the end…
    BioPharma Dive · 13d agoNeutral↗ 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 · 13d agoPositive↗ 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 · 13d 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 · 13d 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 · 13d agoRegulatoryNeutral↗ source
  • Lilly’s ‘triple-G’ drug tops Novo’s Ozempic in diabetes trial
    The highest dose of retatrutide beat Ozempic on measures of blood sugar and weight loss, but was also associated with higher side effect rates and treatment discontinuations.
    BioPharma Dive · 13d ago↗ 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d agoRegulatoryNeutral↗ source
  • Federal judge denies Novo's attempt to block Eli Lilly obesity drug ads
    A federal judge in the U.S. District Court denied Novo Nordisk's request to halt an Eli Lilly advertising campaign that compared the two companies' obesity treatments, Wegovy and Zepbound. Novo ar…
    BioPharma Dive · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d agoRegulatoryNeutral↗ source
  • Ferring to acquire next-gen IVF startup Gameto for up to $1.4B
    The buyout hands Ferring rights to a technology capable of simplifying the lengthy and burdensome process of in vitro fertilization.
    BioPharma Dive · 14d ago↗ source
  • Artiva to quit autoimmune cell therapy work, cut staff after patient deaths
    The disclosure makes Artiva the third company to recently report fatal events in an autoimmune cell therapy trial, following announcements from Novartis and Bristol Myers Squibb.
    BioPharma Dive · 14d ago↗ source
  • Melanoma vaccine shows 42% risk reduction at ESMO 2026, but shares tumble on early data release
    Moderna and Merck presented Phase 3 results for their melanoma vaccine intismeran autogene at the European Society for Medical Oncology meeting. The trial reported a 42% reduction in the relative r…
    BioPharma Dive · 15d agoPositive readoutNeutral↗ 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 · 15d 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 · 15d agoNeutral↗ source