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  • FDA grants tentative approval for Dr. Reddy’s generic HIV prevention shot, expanding access in low- and middle-income countries
    The U.S. Food and Drug Administration has issued a tentative approval for Dr. Reddy’s Laboratories to produce a generic version of a leading HIV prevention medicine. This decision follows months of…
    STAT · 6d agoApprovalPositive↗ source
  • New York records first measles death in three decades as vaccination rates slip
    A child in rural northern New York died after contracting measles, marking the first measles-related death in the state in 30 years, officials said. The death comes as U.S. vaccination coverage ha…
    STAT · 6d agoNegative↗ source
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  • First U.S. bird flu death of 2026 reported in Washington state after cattle exposure
    A person in Washington state died from complications of avian influenza, according to the Associated Press. It is the first bird flu death in the United States this year. The case follows recent r…
    STAT · 6d agoNegative↗ source
  • Compass Pathways leads race for first psychedelic drug approval, non-profit rivals
    Compass Pathways is widely viewed as a leading candidate to bring the first psychedelic medicine to market. The company has advanced its therapy through clinical development and is positioned near…
    STAT · 6d agoNeutral↗ source
  • Midterm elections could reshape health policy, Medicare Advantage and insurance, STAT analysis says
    STAT's D.C. Diagnosis newsletter looks at how the upcoming midterm elections may influence health policy, Medicare Advantage programs and health insurance markets. With record early voting turnout…
    STAT · 6d agoNeutral↗ source
  • FDA and CMS seek state partnerships to shape health AI regulations and liability protections
    The Food and Drug Administration and the Centers for Medicare & Medicaid Services are planning to work with state governments to develop coordinated rules for artificial intelligence used in health…
    STAT · 6d agoRegulatoryNeutral↗ source
  • Mortality rates remain higher in states that supported Trump, highlighting political health divide in 2024
    The UCSF team behind the article notes that health care ranks as the third most important issue for voters in the 2026 midterm election cycle. They found that, after adjusting for age differences,…
    STAT · 6d agoNeutral↗ source
  • Physician finds meditation boosts resilience and patient care after intense trauma cases
    The author, an ophthalmologist at Legacy Devers Eye Institute, attended a meditation retreat in the Santa Cruz Mountains last fall. He describes staying awake through dawn as part of the retreat,…
    STAT · 6d agoPositive↗ source
  • FDA grants tentative approval for generic HIV prevention shot, boosting access in low-income nations
    After months of anticipation, the U.S. Food and Drug Administration issued a tentative approval for Dr. Reddy’s Laboratories to produce a generic version of lenacapavir, the long‑acting injectable…
    STAT · 7d agoRegulatoryPositive↗ source
  • Four major drugmakers allegedly paid tens of millions to Russian middlemen for lifesaving drugs, limiting patient access
    Four large pharmaceutical companies are accused of funneling tens of millions of dollars to Russian intermediaries to deliver essential medicines to government agencies, according to a report by th…
    STAT · 7d agoRegulatoryNegative↗ source
  • Kymera Therapeutics to unveil mid‑stage eczema trial data, aiming to challenge Dupixent
    Kymera Therapeutics, a Massachusetts‑based biotech, is set to release data from its mid‑stage clinical trial of KT‑621 in eczema before the end of 2026. The trial results are being closely watched…
    STAT · 7d agoPositive readoutNeutral↗ source
  • FDA issues final guidance on potency assurance for cell and gene therapy manufacturers
    The FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products. The guidance replaces the agency’s 2011 potency t…
    fda press · 7d agoRegulatoryNeutral↗ source
  • U.S. Health Care System's Economics Are Broken, Says Ascendiun CEO
    Paul Markovich, president and CEO of Ascendiun, argues that the economics of the United States health care system are fundamentally broken. He recounts meeting a healthy, active man in his early 6…
    STAT · 7d agoNegative↗ source
  • Washington resident dies after bird flu infection linked to dairy cattle exposure
    A resident of Yakima County, Washington, died from complications of avian influenza after being exposed to infected cattle at a dairy farm. Health officials said the infection was the H5N1 strain,…
    STAT · 6d agoNegative↗ source
  • Woman travels to Albania for experimental mitochondrial replacement therapy amid global fertility industry concerns
    A STAT reporter detailed a case of a woman named Heidy Willis who, after multiple failed IVF cycles, sought an experimental fertility option abroad. Willis traveled to Albania to undergo mitochond…
    STAT · 7d agoNegative↗ source
  • Women travel abroad for unproven three-parent IVF marketed to older patients
    STAT investigators found that women are journeying thousands of miles to undergo a mitochondrial‑replacement IVF procedure that is promoted as a fertility option for older patients, even though the…
    STAT · 7d agoNegative↗ source
  • Midterm voters weigh health-care costs as urgent-care visits billed like ERs
    The upcoming midterm elections will see tens of millions of voters consider health‑care affordability, especially those whose coverage comes through their employers. The article points out that ri…
    STAT · 7d agoNegative↗ source
  • Early Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+
    The dialyzer connector may not be attached appropriately, resulting in leaking and potential blood loss.
    fda medwatch · 7d agoRegulatoryNeutral↗ source
  • Study finds psilocybin does not produce lasting anxiety or depression relief in mice
    Five Bay Area laboratories joined forces to examine whether a single dose of psilocybin could produce lasting reductions in anxiety and depression-like behavior in mice. The study measured behavior…
    STAT · 7d agoNegative readoutNegative↗ source
  • Cancer can be treated safely during pregnancy, says maternal-fetal specialist
    Elyce Cardonick, a maternal-fetal medicine physician and founder of the Cancer and Pregnancy Registry, argues that pregnant cancer patients are often urged to terminate their pregnancies even thoug…
    STAT · 7d agoPositive↗ source
  • STAT calls for input on mitochondrial replacement therapy used in fertility tourism
    STAT is asking patients and clinicians to share their experiences with mitochondrial replacement techniques (MRT), sometimes called three-parent IVF, which are being marketed as a fertility option…
    STAT · 7d agoNeutral↗ source
  • FDA warns against Once Upon a Farm Tractor Wheels toddler bars due to choking risk
    The U.S. Food and Drug Administration issued a consumer safety advisory concerning the organic toddler snack Once Upon a Farm Tractor Wheels. The agency cautioned that the soft‑baked bars pose a p…
    fda medwatch · 7d agoRegulatoryNegative↗ source
  • Midterm election outcomes could reshape U.S. health policy, experts say
    The article notes that regardless of the results, the upcoming midterm elections will have broad effects on the U.S. health system, according to more than two dozen policymakers, lobbyists and expe…
    STAT · 9d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 9d agoApprovalPositive↗ source
  • Instrumentation Laboratories recalls several lots of HemosIL AcuStar HIT-IgG(PF4-H) assay due to false-negative risk
    Instrumentation Laboratories (Werfen) has issued a recall of specific lots of its HemosIL AcuStar HIT-IgG(PF4-H) radioimmunoassay after the FDA identified a performance issue that could produce fal…
    fda medwatch · 10d agoCRLNegative↗ source