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3,078 stories matching this filter · ← front page

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  • Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout
    Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.
    BioSpace · 13d ago↗ source
  • Lilly’s retatrutide trounces Novo’s Ozempic in diabetes, weight loss
    Eli Lilly’s next-gen weight loss drug retatrutide soundly beat Novo’s approved medicine Ozempic in weight loss and blood sugar reduction, padding the case for a regulatory application that’s expect…
    BioSpace · 13d ago↗ source
  • Lilly's triple-G drug retatrutide outshines Novo's Ozempic in diabetes
    Eli Lilly’s retatrutide, the incretin shot that has already proven its effectiveness against other assets on a cross-trial basis, has cemented its utility in a head-to-head trial, albeit in diabete…
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fda medwatch111
globenewswire health73
fda press59
1794
Psychiatry & CNS1204
Ophthalmology1050
Endocrinology & Metabolism775
Pain775
Nephrology759
Endpoints · 13d ago
↗ source
  • Incyte's KRAS G12D inhibitor shows 89% response rate in early pancreatic cancer trial
    In a Phase 1 study, Incyte tested its KRAS G12D inhibitor together with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma carrying the G12D mutation. The combinati…
    BioSpace · 14d agoPositive readoutPositive↗ source
  • Novartis takes $1.9B write-down after Avidity's del-desiran fails Phase 3 but reaffirms confidence in $12B acquisition
    Novartis announced a $1.9 billion partial impairment after the Phase 3 HARBOR study of del-desiran, an antibody‑oligonucleotide conjugate from its Avidity Biosciences acquisition, did not meet its…
    BioSpace · 14d agoNegative readoutNeutral↗ source
  • Novartis reaffirms $12 billion Avidity acquisition despite $1.9 billion impairment loss
    Novartis said its $12 billion purchase of Avidity Biosciences remains on track, according to CEO Vas Narasimhan. The comment followed the company's disclosure of a $1.9 billion impairment charge t…
    Endpoints · 14d agoDealNeutral↗ 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
  • US Treasury draft COINS rules could sharply limit China biotech partnerships
    US Treasury released a draft set of regulations known as the COINS rule that targets cross-border biotech transactions. The proposal would bar certain US-China deals and tighten oversight of collab…
    Endpoints · 14d agoRegulatoryNegative↗ 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
  • Ferring agrees to buy fertility startup Gameto in deal up to $1.38 billion
    Ferring Pharmaceuticals announced it has signed an agreement to acquire Gameto, a biotech company developing an ovary-in-a-dish platform for fertility treatments. The transaction is structured as…
    Endpoints · 14d agoDealNeutral↗ source
  • Novartis weighs private-pay launches in Europe as MFN rules pressure government pricing
    Novartis CEO Vas Narasimhan said the company is exploring the option of introducing new medicines directly to private or self‑pay patients in Europe. The discussion is driven by the European Union…
    Endpoints · 14d agoRegulatoryNegative↗ 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
  • Artiva Biotherapeutics to cease operations after two deaths in autoimmune cell therapy trials
    Artiva Biotherapeutics announced it will wind down and lay off nearly all staff following two patient fatalities in its autoimmune cell therapy trials. The deaths occurred during clinical testing…
    Endpoints · 14d agoNegative↗ source
  • Biopharma optimism climbs after FDA commissioner Makary's exit, survey finds
    Endpoints Signal released its Q3 Biopharma Sentiment Index, showing the highest level of industry optimism in years, according to a survey of 569 insiders. The index’s regulatory score rose sharpl…
    Endpoints · 14d agoRegulatoryPositive↗ source
  • Alphabet’s GV tops biotech corporate investors with $5.23 billion in deals since 2025
    Alphabet’s venture arm GV has become the largest corporate spender in biotech, investing a cumulative $5.23 billion across 20 deals since the start of 2025. The total outlay exceeds the combined v…
    BioSpace · 14d agoNeutral↗ 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
  • Gubra aims to expand beyond obesity drugs, targets first portfolio partner this year
    Copenhagen‑based biotech Gubra is currently known for its obesity drug candidates, but the company says its long‑term growth will depend on a broader pipeline beyond metabolism. The firm’s existin…
    Endpoints · 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
  • U.S. judge rejects Novo Nordisk's bid to block Eli Lilly obesity drug ads
    A U.S. federal judge denied Novo Nordisk's request to halt television advertisements by Eli Lilly for its obesity treatments. Novo had argued the ads were misleading and sought an injunction, but…
    Endpoints · 14d agoRegulatoryNegative↗ source
  • Anthropic acquires one-person biotech Mithril Medicine to expand into life sciences
    Anthropic, known for its artificial intelligence work, announced it has purchased Mithril Medicine, a drug discovery startup run by a single individual. The deal is presented as a step in Anthropi…
    Endpoints · 14d agoDealNeutral↗ source
  • Mennonite family backs new gene-therapy startup
    A new gene‑therapy company is taking shape with financial support from members of the Amish and Mennonite communities. The story highlights the unusual partnership between a traditional religious g…
    Endpoints · 14d agoDealNeutral↗ source