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  • UniQure to release four-year Huntington’s gene therapy results by September
    UniQure, a biotech firm, will report four-year data from its Huntington’s disease gene therapy trial before the end of September. The therapy, AMT-130, has already been submitted to regulators in…
    STAT · 2d agoPositive readoutNeutral↗ source
  • FDA signals openness to innovative approaches for psychedelic drug development
    FDA officials said the agency is open to novel, innovative approaches to the clinical development of psychedelic drugs, citing the worsening mental health crisis in the United States. The agency’s…
    raps · 2d agoRegulatoryNeutral↗ source
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  • EMA revises GVP inspection guideline to incorporate new subcontractor rules
    The European Medicines Agency has issued an update to its guideline on good pharmacovigilance practice inspections. The revision aligns the guidance with recent changes to the rules governing subco…
    raps · 2d agoRegulatoryNeutral↗ source
  • Trump officials turn to AI to address rural health care challenges as nominees await Senate confirmation
    The article notes that nominees for top federal health positions will soon be questioned by Congress, highlighting upcoming scrutiny of health leadership. It also reports that officials in the Tru…
    STAT · 2d agoNeutral↗ source
  • CMS chief Mehmet Oz touts AI avatars for rural health, but some hospital leaders remain skeptical
    Centers for Medicare and Medicaid Services (CMS) head Mehmet Oz announced that artificial-intelligence based avatars could help deliver medical care to patients in rural communities. The proposal…
    STAT · 2d agoNeutral↗ source
  • Evergreen Fresh Sprouts recalls 215 cases of broccoli sprouts over possible Salmonella contamination
    Evergreen Fresh Sprouts LLC of Moyie Springs, Idaho announced a recall of 215 cases of its broccoli sprouts due to potential Salmonella contamination. The product, packaged in 4‑oz zip‑lock bags,…
    fda recalls · 2d agoRegulatoryNegative↗ source
  • Trump administration touts AI as solution for rural health care, experts remain skeptical
    Rural health care providers are confronting nearly $1 trillion in Medicaid cuts projected over the next decade, prompting the Trump administration to promote artificial intelligence tools as a resc…
    STAT · 2d agoNeutral↗ source
  • Senator John Fetterman's post-stroke conduct sparks debate on brain health and politics
    Neurologists Michael P.H. Stanley and Isaiah Kletenik wrote an opinion piece highlighting how Senator John Fetterman's behavior after his 2022 stroke has become a focal point for discussions about…
    STAT · 2d agoNegative↗ source
  • ARPA-H commits $62.7 million to develop FDA-authorized AI for heart-failure treatment
    ARPA-H announced a $62.7 million investment to create artificial-intelligence systems that can assist in treating heart failure. The program, called ADVOCATE, seeks to develop partially autonomous…
    STAT · 3d agoDealPositive↗ source
  • Scientists who discovered orexin receive Lasker Award as FDA appoints permanent heads of key drug and biologics centers
    The team that identified the orexin system has been honored with a Lasker Award, one of the nation’s most prestigious biomedical recognitions. The award highlights the impact of their work on under…
    STAT · 3d agoPositive↗ source
  • AstraZeneca's COPD drug cuts flare-ups in late-stage trials, offering new option for patients
    In two late-stage studies, an AstraZeneca therapy showed a statistically significant reduction in acute exacerbations that worsen chronic obstructive pulmonary disease. The data, released on Tuesda…
    STAT · 3d agoPositive readoutPositive↗ source
  • UK commission proposes new framework to regulate AI-driven medical tools
    A UK commission released a report on Thursday outlining 44 recommendations for how artificial intelligence should be governed in the medical sector. The guidance aims to capture AI's promise, such…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Caspian Therapeutics launches with $50M to develop menin inhibitors for diabetes and cardiometabolic disease
    Caspian Therapeutics, a spin‑out from Kura Oncology, announced it is starting operations with $50 million in financing. The capital, led by BVF Partners and joined by Eli Lilly and Kura leadership,…
    STAT · 3d agoDealPositive↗ source
  • AMA chief says AI will augment, not replace, physicians
    John Whyte, the chief executive of the American Medical Association, wrote an opinion piece asserting that artificial intelligence should work alongside doctors rather than take their place. He po…
    STAT · 3d agoPositive↗ source
  • Opinion: Autonomous AI could surpass AI-assisted doctors on key tasks by 2030
    The piece, authored by Ezekiel J. Emanuel and Abe Baker-Butler, argues that autonomous artificial intelligence is likely to outpace both unaided physicians and those using AI assistance on five cor…
    STAT · 3d agoNeutral↗ source
  • FDA appoints permanent heads of drug, biologics and tobacco centers and adds AI deputy commissioner
    The U.S. Food and Drug Administration announced permanent appointments for the leaders of its major product centers. The Center for Drug Evaluation and Research and the Center for Biologics Evalua…
    raps · 3d agoRegulatoryNeutral↗ source
  • Telemedicine firm begins offering GLP-1 medications to treat addiction
    A telemedicine company announced it will now prescribe GLP-1 class drugs to patients with substance-use disorders through its virtual platform. GLP-1 medications, originally approved for diabetes…
    STAT · 3d agoNeutral↗ source
  • AI tools struggle to improve emergency room workflow, study finds
    The article notes that CEOs of leading AI firms have promised dramatic health benefits, but real‑world testing in emergency departments tells a different story. At Brigham and Women’s Hospital, th…
    STAT · 3d agoNegative↗ source
  • Two infants die in Pennsylvania measles outbreak, coroner confirms one death caused by virus
    Pennsylvania’s health coroner released details about two infant deaths that occurred during a growing measles outbreak in the state. The first infant, Ivan Miller, died on Aug. 14 shortly after bi…
    STAT · 3d agoNegative↗ source
  • AI cannot solve emergency-room woes, highlighting broader health-care challenges
    The recent STAT AI Prognosis newsletter notes that artificial intelligence is unable to address the core problems facing emergency rooms, suggesting that technology alone cannot fix systemic issues…
    STAT · 3d agoNegative↗ source
  • FDA approves Revolution Medicines’ pancreatic cancer drug Rasonque, but patients face delayed access
    The U.S. Food and Drug Administration has granted approval to Rasonque, a new therapy for pancreatic cancer developed by Revolution Medicines. The decision follows clinical data that showed the dru…
    STAT · 4d agoApprovalNeutral↗ source
  • AstraZeneca’s experimental COPD drug tozorakimab cuts flare-ups by 30% in Phase 3 trials
    In two Phase 3 studies, AstraZeneca’s injectable COPD candidate tozorakimab reduced the rate of disease exacerbations by roughly 30%, according to data released on Tuesday. The trials measured flar…
    STAT · 4d agoPositive readoutPositive↗ source
  • FDA approves AstraZeneca's new breast cancer therapy
    The U.S. Food and Drug Administration has granted approval for AstraZeneca's latest breast cancer drug, expanding treatment options for patients with the disease. The approval follows a review of…
    STAT · 4d agoApprovalPositive↗ source
  • Roivant's experimental pulmonary hypertension drug meets Phase 2 goals
    Roivant announced that its experimental drug mosliciguat achieved the primary endpoint in a 16‑week Phase 2 trial for pulmonary hypertension, a serious lung condition. The study showed a 56% reduc…
    STAT · 4d agoPositive readoutPositive↗ source
  • Novartis' DM1 drug del-desiran misses primary endpoint in Phase 3 HARBOR trial
    Novartis announced that its experimental therapy del-desiran did not improve muscle function in a pivotal Phase 3 study for myotonic dystrophy type 1 (DM1). The trial, called HARBOR, evaluated the…
    STAT · 4d agoNegative readoutNegative↗ source