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  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 6h agoApprovalPositive↗ source
  • Latigo's mid-stage trial shows non-opioid pill LTG-001 cuts post-surgery pain, outperforms placebo
    Latigo Biotherapeutics reported positive Phase 2 data for its experimental oral analgesic LTG-001, tested in patients who had undergone tummy-tuck surgery. The study enrolled 343 participants who w…
    STAT · 1h agoPositive readoutPositive↗ source
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  • Trump administration ends Medicare drug plan subsidies, raising cost concerns ahead of midterms
    The White House announced that subsidies for private Medicare prescription drug plans will be discontinued, a move expected to increase premiums for many seniors. The policy shift comes as Democra…
    STAT · 7h agoRegulatoryNegative↗ source
  • Former VA Secretary argues the Veterans Health Administration can boost US biotech competitiveness against China
    The piece, authored by former Veterans Affairs Secretary David Shulkin, positions the VA as a critical component of America’s biotechnology ecosystem alongside HHS and the Department of Defense. H…
    STAT · 14h agoNeutral↗ source
  • Study finds clinical chatbots lag behind general AI models in accuracy, sparking debate among doctors
    Hundreds of thousands of U.S. physicians are using clinical large language model tools marketed by firms such as OpenEvidence, Doximity and UpToDate as safer alternatives to generic AI chatbots. A…
    STAT · 14h agoNegative readoutNegative↗ source
  • FTC sues Hims & Hers for misleading consumers and privacy violations
    The Federal Trade Commission, joined by Utah and California, filed a lawsuit against Hims & Hers, a direct-to-consumer telehealth provider, alleging deceptive business practices. The complaint say…
    STAT · 3h agoRegulatoryNegative↗ source
  • Fugitive Discovered Working Under Alias in Biotech Industry Amid Legal Battles Involving AstraZeneca and Lilly
    A Rhode Island fugitive who had been on the most-wanted list was recently uncovered as having worked under a false identity in the biotech sector. The revelation raised questions about how the ind…
    STAT · 8h agoNegative↗ source
  • STAT+: FDA expert panel recommends against approval of Capricor’s Duchenne drug
    STAT is live-blogging an FDA meeting on Capricor Therapeutics’ treatment for Duchenne muscular dystrophy, which has been the subject of a contentious regulatory review.
    STAT · 12h agoRegulatoryNeutral↗ source
  • NSF launches $47 million pilot to create joint university-industry Ph.D. programs for life scientists
    The National Science Foundation, with funding announced by the Trump administration, is testing a new Ph.D. training model that blends academic study with industry experience. The $47 million pilo…
    STAT · 57m agoPositive↗ source
  • Prolonged hospital stays leave children isolated, urging change
    An author visiting a pediatric ward describes a young, nonverbal child with severe developmental delays who has been waiting months for a life-saving liver transplant. The child lies in a stark, ma…
    STAT · 14h agoNegative↗ source
  • Most-wanted fugitive Ronald Fischer operated under alias in biotech industry for two decades
    A Rhode Island man on the most-wanted list was recently uncovered as a hidden employee in the biotech sector, having worked under a false identity for about twenty years. The individual, identifie…
    STAT · 14h agoNegative↗ source
  • Fauci invokes Fifth Amendment, declines to answer Covid-19 origins questions at Senate hearing
    At a Senate hearing on Wednesday, former U.S. health chief Anthony Fauci invoked his Fifth Amendment right and refused to answer lawmakers' questions about the Covid-19 pandemic and its origins. F…
    STAT · 9h agoRegulatoryNeutral↗ source
  • Morning Rounds flags overlooked pedestrian and cyclist deaths, upcoming Fauci Senate hearing, and research visa limits
    The latest Morning Rounds newsletter draws attention to the often‑ignored problem of deaths among pedestrians and cyclists, urging greater public health focus. It also notes that Dr. Anthony Fauci…
    STAT · 10h agoNeutral↗ source
  • Merck posts—then pulls—trial plan for PD-1xVEGF and TROP2 ADC combination
    After keeping tight-lipped for nearly two years, Merck & Co. briefly dropped the first concrete hint as to where it intends to take its PD-1xVEGF bispecific antibody—before quietly scrubbing the ev…
    Fierce Biotech · 8h ago↗ source
  • STAT+: Why benchmarking clinical LLMs from OpenEvidence, Doximity is complicated
    In this edition of AI Prognosis: A conversation about benchmarking leading clinical chatbots, investor view on AI in biopharma, and more.
    STAT · 9h ago↗ source
  • ‘Low tech’ chemotherapy nanoparticles show promise for deadly brain tumor recurrence
    A standard chemotherapy drug loaded in nanoparticles has been able to penetrate the blood-brain barrier when administered shortly after resection of the tumor, new research has suggested.
    Fierce Biotech · 10h ago↗ source
  • ‘We have what we need to grow:’ Biogen CEO happy to ease off the M&A for a while
    Biogen's business development team may have been busy in recent years, but CEO Christopher Viehbacher is easing off the acquisitions for a while.
    Fierce Biotech · 11h ago↗ source
  • Novo Nordisk fails to dismiss lawsuit over CagriSema readout
    Novo Nordisk’s attempt to dismiss a lawsuit about its CagriSema readout has failed, with the judge ruling that parts of the investors’ argument were strong enough for the case to proceed.
    Fierce Biotech · 12h ago↗ source
  • Processa acquires Vidya for potential BTK inhibitor rival to Novartis’ Rhapsido
    Processa Pharmaceuticals has made a push into the autoimmune space via the acquisition of Vidya Therapeutics, which delivers a potential rival to Novartis’ Rhapsido.
    Fierce Biotech · 12h ago↗ source
  • ‘Reverse mergers are increasingly popular’: Caldera hops on Synlogic’s Nasdaq listing
    Caldera Therapeutics has struck a reverse merger with the publicly traded Synlogic and inked a $278 million financing deal, continuing the meteoric rise of the inflammatory bowel disease startup.
    Fierce Biotech · 13h ago↗ source
  • Vertex’s latest autoimmune TCE play involves $28M upfront to AbCellera
    AbCellera’s T-cell engager platform has reeled in a second client this summer, with Vertex paying $28 million upfront for a collaboration that will include autoimmune conditions.
    Fierce Biotech · 14h ago↗ source
  • Visa time limits on foreign Ph.D. students and postdocs will harm U.S. science, experts warn
    A Trump administration plan to limit visas for graduate student and postdocs to four years is fueling concerns that the U.S. could lose out on foreign scientists
    STAT · 1d agoApprovalPositive↗ source
  • STAT+: Preliminary trial results suggest a path to a safer Alzheimer’s treatment
    ProMIS Neurosciences is trying to design a safer amyloid-clearing drug for Alzheimer's. Early results suggest it might be on to something.
    STAT · 1d agoApprovalPositive↗ source
  • Boston Scientific unveils major restructuring, plots job cuts amid savings drive
    Medical device maker Boston Scientific has been a prolific dealmaker this year but is now taking a step back as it looks to make changes internally.
    Fierce Biotech · 1d agoLayoffsNegative↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 1d agoRegulatoryNeutral↗ source