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2,516 stories matching this filter · ← front page

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  • City Therapeutics completes $200 million IPO, earmarks funds for RNAi therapies
    City Therapeutics, based in Cambridge, Massachusetts, launched an IPO raising $200 million, exceeding its original target of 9.7 million shares at $17-$19 per share. The company sold 11.1 million…
    Fierce Biotech · 4d agoDealPositive↗ 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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
  • Labcorp teams with Thrive Global to launch Thrive 5 home health test
    Labcorp has introduced the Thrive 5 Health Test in partnership with Arianna Huffington's company, Thrive Global. The test is sold through Labcorp's OnDemand home testing service and pairs laborato…
    Fierce Biotech · 4d agoPositive↗ 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
  • FDA issues early alert for Edwards Lifesciences’ mitral valve delivery system after reported death, injury
    The FDA has issued an early alert for certain delivery systems used with Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement system amid serious safety concerns.
    Fierce Biotech · 4d ago↗ source
  • Vanda pauses social anxiety program after ex-Novartis asset flunks phase 3 study
    A phase 3 trial of Vanda Pharmaceuticals’ social anxiety disorder drug candidate has missed its primary endpoint, prompting the company to put the program on hold.
    Fierce Biotech · 5d agoNegative readoutNegative↗ 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 · 4d agoDealPositive↗ source
  • FDA launches Rare Disease Framework Initiative to overhaul review process
    The FDA announced a new Rare Disease Framework Initiative aimed at redesigning how therapies for rare conditions are regulated. The initiative will move away from a one-size-fits-all model, instea…
    BioPharma Dive · 4d agoRegulatoryPositive↗ source
  • Estuary Biotherapeutics raises $103M to advance gene therapies for polycystic kidney disease
    Estuary Biotherapeutics announced it has exited stealth mode after securing $103 million in financing to move two gene‑therapy candidates into clinical testing for autosomal dominant polycystic kid…
    Fierce Biotech · 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
  • AstraZeneca signs $1.5B AI partnership with insitro to discover liver and heart disease targets
    AstraZeneca announced a partnership with insitro, a biotech that uses artificial intelligence, with an upfront payment of $40 million and potential milestones up to $1.46 billion. The collaboratio…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Iambic Therapeutics raises $150 million in IPO to fund oncology drug development
    Iambic Therapeutics, a San Diego-based AI biotech, completed an initial public offering that raised $150 million, exactly meeting its goal of selling 9.4 million shares at $16 each. The company sa…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Iambic Therapeutics raises $150 million in IPO, begins Nasdaq trading under ticker IAM
    Iambic Therapeutics, an AI-driven drug discovery startup, completed an initial public offering that raised $150 million. The company sold about 9.4 million shares at $16 each and will start tradin…
    BioPharma Dive · 5d agoDealPositive↗ 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
  • IQVIA urges early clinical insight in drug discovery to boost patient benefit
    IQVIA Laboratories' leaders argue that drug discovery and clinical development should be linked early to improve patient outcomes. They explain that decisions made during discovery affect later cl…
    Fierce Biotech · 4d agoPositive↗ source
  • Belgian startup Armed Cell Therapeutics acquires Galapagos-derived CAR-T assets for €8 million upfront
    Armed Cell Therapeutics, a new Belgian biotech chaired by former Galapagos CEO Paul Stoffels, has taken ownership of several cell therapy programs previously held by Lakefront Biotherapeutics. The…
    BioPharma Dive · 4d agoDealPositive↗ source