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2,247 stories matching this filter · ← front page

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  • 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
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  • 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
  • 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 · 5d agoDealPositive↗ 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
  • 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 · 5d agoPositive↗ 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
  • OrbiMed raises $3 billion, its biggest Asian fund yet, to boost biotech investments worldwide
    OrbiMed announced it has closed a $3 billion fundraising round, the largest ever for its Asia‑focused vehicle. The capital will be used to make new growth‑equity and venture investments in biotech…
    Fierce Biotech · 5d agoDealPositive↗ 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
  • SimBioSys receives FDA clearance for Nvidia-powered AI tool to predict breast cancer recurrence
    SimBioSys announced FDA clearance for its TumorSight Risk platform, an AI-driven tool that uses MRI, pathology and clinical data to assess the likelihood of breast cancer returning. The cloud-base…
    Fierce Biotech · 5d agoRegulatoryPositive↗ 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
  • Osivax’s flu vaccine OVX836 misses primary efficacy goal in phase 2b trial
    Osivax announced that its influenza A vaccine candidate OVX836 failed to meet the primary efficacy endpoint in a phase 2b trial involving 2,850 healthy adults in Europe. The trial showed a vaccine…
    Fierce Biotech · 5d agoNegative readoutNegative↗ source