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1,745 stories matching this filter · ← front page

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  • EU regulators endorse Eli Lilly’s oral GLP-1 pill orforglipron
    The European Medicines Agency’s human medicines committee (CHMP) has given a positive opinion on Eli Lilly’s oral GLP-1 medication, orforglipron, providing the drug with EU regulatory backing. The…
    Endpoints · 4d agoRegulatoryNeutral↗ source
  • FDA issues warning letters to drug makers and a lab over CGMP and GLP violations
    FDA sent warning letters to several drug manufacturers for not meeting current good manufacturing practice (CGMP) requirements. The letters point to issues such as ensuring final product sterility…
    raps · 4d agoRegulatoryNegative↗ source
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  • Sanofi appoints former Roche exec Paulo Fontoura as global R&D head, eyes AI and dealmaking
    Sanofi announced that Paulo Fontoura, who spent 16 years at Roche and most recently worked at AI drug discovery startup Xaira Therapeutics, has become the company’s global head of R&D as of Septemb…
    Endpoints · 4d agoNeutral↗ source
  • China moves to ban export of select biotech platforms while keeping drug licensing open
    Chinese Ministry of Commerce announced it is pursuing an export ban on certain biotechnology platforms. The measure is intended to restrict the types of deals domestic companies can make abroad, r…
    Endpoints · 4d agoRegulatoryNeutral↗ source
  • FDA reviews interim access policy for compounded peptides as Enspryng label expands
    The U.S. Department of Health and Human Services and the Food and Drug Administration have drafted a new interim access policy that would allow compounding pharmacies to use certain peptide drugs u…
    Endpoints · 4d agoRegulatoryNeutral↗ source
  • Eli Lilly signals interest in researching and improving psychedelic ibogaine, says neuroscience chief
    At a recent psychedelics conference, Eli Lilly’s neuroscience president Carole Ho announced the company’s interest in studying ibogaine. Ho said Lilly aims to improve the drug’s safety and efficac…
    Endpoints · 4d agoPositive↗ source
  • Study shows clinicians increasingly turn to AI for medical queries despite limited evidence of impact
    New research examined usage data from OpenEvidence, an AI search platform, to track how clinicians use AI to answer medical questions. Findings show a rapid increase in the frequency of AI queries…
    Endpoints · 4d agoNeutral↗ source
  • Former Genentech researcher Lélia Delamarre appointed head of R&D at Medici Therapeutics; Intellia hires Scholar Rock CMO
    Lélia Delamarre, a former senior scientist at Genentech, announced on LinkedIn that she will lead research and development at Medici Therapeutics, a cancer‑focused biotech backed by ARCH venture pa…
    Endpoints · 4d agoNeutral↗ source
  • Lidl US recalls Gelatelli Coffee & Vanilla Gelato over possible Listeria contamination
    Lidl US announced a recall of one lot of its Gelatelli Coffee & Vanilla Gelato with coffee sauce and cookie pieces, citing potential contamination with Listeria monocytogenes. The affected product…
    fda recalls · 4d agoCRLNegative↗ source
  • Estuary debuts with $103M to develop kidney disease gene therapies
    Estuary Biotherapeutics raised the curtain on Friday with $103 million to support the advancement of two preclinical gene therapy candidates for the most common type of inherited kidney disease. Th…
    Endpoints · 4d ago↗ source
  • Virginia secures $12.6 billion in onshoring commitments as Trump pushes drugmakers to expand US manufacturing
    The Commonwealth of Virginia is emerging as a leading destination for pharmaceutical manufacturing investments after recent policy encouragement from the White House. President Donald Trump has ur…
    Endpoints · 4d agoDealPositive↗ source
  • AstraZeneca signs $40 million AI drug-discovery deal with insitro as inVIOs reports Phase 1 tumor success
    AstraZeneca announced a partnership with insitro, a California AI‑driven drug discovery firm, agreeing to pay $40 million upfront for collaboration. The agreement aims to combine AstraZeneca’s the…
    Endpoints · 5d agoDealPositive↗ source
  • Oxford biotech OMass Therapeutics secures $310 million to advance genetic adrenal disorder program
    Oxford-based OMass Therapeutics announced a $310 million private financing round, one of the largest recent fundraises for a UK biotech. The capital will fund the development of therapies targetin…
    Endpoints · 5d agoDealNeutral↗ source
  • Experts call for dedicated regulatory framework for clinical AI models, UK MHRA unveils AI-focused strategy
    Former FDA commissioner Scott Gottlieb, now at the American Enterprise Institute, wrote an opinion piece urging Congress to create a specific regulatory framework for artificial intelligence models…
    raps · 5d agoRegulatoryPositive↗ source
  • EMA to cement ACT EU pilot; MHRA unveils AI-era regulatory strategy
    The European Medicines Agency announced that in January 2027 it will make permanent a pilot project that assists sponsors in preparing clinical trial applications, turning a temporary scheme into a…
    raps · 5d agoRegulatoryNeutral↗ source
  • OrbiMed secures $3 billion for new life science funds, with over $1 billion earmarked for Asia
    OrbiMed, a leading global investor in life science companies, announced the closing of two new funds that together total about $3 billion. The capital will be deployed across a range of private equ…
    Endpoints · 5d agoDealPositive↗ source
  • Vanda pauses social anxiety program after Phase 3 trial misses endpoint in women
    Vanda Pharmaceuticals announced Wednesday that it is halting development of its social anxiety disorder candidate after a late-stage trial did not achieve its primary goal. The experimental drug,…
    Endpoints · 5d agoNegative readoutNegative↗ source
  • Nvidia-backed Iambic Therapeutics raises $150M in IPO, begins trading Thursday
    Iambic Therapeutics, a biotech focused on using artificial intelligence to develop cancer treatments, announced the completion of its initial public offering. The company sold 9.38 million shares…
    Endpoints · 5d agoDealPositive↗ source
  • FDA issues warning letters to manufacturers over CGMP and GLP violations
    The U.S. Food and Drug Administration has sent warning letters to multiple drug manufacturers for failing to meet current good manufacturing practice requirements. The agency highlighted problems e…
    raps · 5d agoRegulatoryNegative↗ source
  • Former Galapagos CEO Paul Stoffels aims to revive cell therapy projects at new biotech Armed Cell
    Paul Stoffels, who recently stepped down as chief executive of Belgian drug developer Galapagos, is turning his attention to cell‑based therapies. After leaving Galapagos last year, Stoffels has j…
    Endpoints · 5d agoDealPositive↗ source
  • Experts call for Congress to create a dedicated regulatory framework for AI models used in academic medical centers
    On Oct. 15, 2026, several health policy experts voiced support for a new regulatory approach specifically aimed at clinical artificial‑intelligence models that are developed and deployed in academi…
    raps · 5d agoRegulatoryNeutral↗ source
  • Family Farmstead Dairy Announces Recall of Raw Mild Cheddar Cheese Due to Potential E. coli O157:H7 Contamination
    WORCESTER, NY, October 15, 2026 - Family Farmstead Dairy of Worcester, NY is recalling specific lot of cheddar cheese because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli…
    fda recalls · 4d agoRegulatoryNeutral↗ source
  • Osivax shifts to combination strategy after Phase 2b flu vaccine setback
    Osivax, a French biotech, reported that its lead influenza vaccine candidate did not meet primary endpoints in a Phase 2b study. The trial, which evaluated the vaccine as a standalone product, sho…
    Endpoints · 5d agoNegative readoutNegative↗ source
  • AI tools push physicians to prioritize clinical reasoning over memorization, experts say
    During a recent Endpoints News panel, health‑tech experts highlighted how artificial‑intelligence applications are reshaping the competencies doctors need. They argued that AI can handle routine d…
    Endpoints · 5d agoPositive↗ source
  • NorthStar Medical Technologies partners with Chinese CRO Quarkmed, while Lonza outlines mid-term guidance
    NorthStar Medical Technologies, a maker of radioisotopes, announced a new partnership with Beijing-based contract research organization Quarkmed. Under the agreement, Quarkmed will provide contrac…
    Endpoints · 5d agoDealNeutral↗ source