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  • 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 · 1mo 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 · 1mo agoDealPositive↗ source
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  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoNegative readoutNegative↗ source
  • Novartis' experimental drug fails pivotal trial for rare neuromuscular disease
    Novartis reported that its experimental therapy for a rare neuromuscular disorder did not improve muscle function in a pivotal study, missing its primary endpoints. The failure represents the comp…
    STAT · 1mo agoNegative readoutNegative↗ source
  • Rural hospitals seek partnership deals as Trump Medicaid cuts threaten financial stability
    Rural health systems are looking for mergers or partnership agreements to stay afloat as the Trump administration prepares unprecedented cuts to Medicaid funding. The anticipated reductions are pr…
    STAT · 1mo agoDealNegative↗ source
  • FDA makes permanent four key leadership appointments, including first AI deputy commissioner
    The Food and Drug Administration announced that three officials who have been serving in acting capacities will now be confirmed as permanent heads of its major centers. Michael Davis, a psychiatr…
    STAT · 1mo agoRegulatoryPositive↗ source
  • FDA halts US shipments from Shoolin Pharma after unsanitary inspection findings
    The Food and Drug Administration issued a warning letter to Shoolin Pharma after an April inspection uncovered unsanitary conditions at its Gujarat facility. The letter cited residue and stains on…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Inhibrx reports promising responses to OX40 immunotherapy in HPV-positive head and neck cancer
    Inhibrx announced that its experimental immunotherapy targeting the protein OX40 produced measurable responses in patients with head and neck cancer, with the clearest activity observed in a small…
    STAT · 1mo agoPositive readoutPositive↗ source
  • FDA approves AstraZeneca breast cancer drug despite negative advisory committee vote; Novartis faces cholesterol drug setbacks
    The U.S. Food and Drug Administration granted approval to AstraZeneca's breast cancer therapy even though the advisory committee voted against it. The decision underscores the agency's willingness…
    raps · 1mo agoRegulatoryNeutral↗ source
  • UnitedHealth executives donate heavily to Rep. Katherine Clark as No Surprises Act debate intensifies
    UnitedHealth Group's senior leadership, including CEO Stephen Hemsley, recently made sizable campaign contributions to Rep. Katherine Clark of Massachusetts. Clark, the House Democratic leader who…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Democrats outline health-care priorities as they aim to retake House before November midterms
    The article notes that Democrats are sharpening their health‑care proposals as the November midterm elections approach, signaling a more detailed agenda should they regain control of the House. Ho…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Administrative gap stalls access to new pancreatic cancer therapy
    A recent Morning Rounds report notes that patients awaiting a new pancreatic cancer treatment are encountering delays because an administrative gap has halted its rollout. The story explains that…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Reynolds launches fruit-flavored Vuse Pro vapes in Ohio despite lacking FDA authorization
    Reynolds American has begun selling its Vuse Pro e‑cigarettes in four new flavors-peach, berry, watermelon and fresh mint-at a GetGo station in suburban Ohio and in a few other states. The product…
    STAT · 1mo agoRegulatoryNegative↗ source
  • EMA publishes guidance on voluntary electronic product information submissions for EU MAAs
    The European Medicines Agency released new guidance detailing how companies should provide electronic product information (ePI) when filing marketing authorization applications under the EU's centr…
    raps · 1mo agoRegulatoryNeutral↗ source