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2,152 stories matching this filter · ← front page

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  • Biotech startups opt out of AI for drug discovery, say STAT
    The latest STAT AI Prognosis newsletter notes that a number of biotech startups are deliberately avoiding artificial intelligence in their drug discovery programs. These companies argue that AI ma…
    STAT · 5d agoNeutral↗ source
  • Massachusetts voters reject repeal of recreational cannabis sales, keeping industry open
    Voters in Massachusetts decisively rejected Question 8, a ballot initiative that sought to dismantle the state’s recreational cannabis industry. Approximately 76% of voters cast ballots against th…
    STAT · 5d agoRegulatoryPositive↗ source
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  • MAHA movement faces uncertain future after midterm losses
    Midterm elections swept many of the Make America Healthy Again (MAHA) coalition’s allies out of office, leaving the group led by health secretary Robert F. Kennedy Jr. with a reduced political base…
    STAT · 5d agoNegative↗ source
  • American expatriate in Malta finds free health care but misses digital patient portal
    Mariska Breland, an American co‑founder of The Neuro Studio, moved to Malta seeking free health care and recounts her first visit to a local general practitioner. She describes a modest clinic wit…
    STAT · 5d agoNeutral↗ source
  • Servier’s $1.55 billion Becker muscular dystrophy drug fails pivotal Phase 3 trial
    Servier announced that its experimental drug for Becker muscular dystrophy did not meet its primary endpoint in a Phase 3 trial called GRAND CANYON. The drug, sevasemten, was acquired from Edgewis…
    STAT · 5d agoNegative readoutNegative↗ source
  • Scientists question safety and benefits of three-parent IVF as new UK data raise concerns
    The mitochondrial replacement technique, often called three‑parent IVF, was hailed after the United Kingdom reported the birth of eight healthy children whose mothers carried disease‑causing mitoch…
    STAT · 6d agoRegulatoryNegative↗ source
  • Compact Medical issues recall and updated instructions for ButterflyBVM bag-valve-mask resuscitators due to bellows holes
    The FDA's Center for Devices and Radiological Health has issued an early alert about a potential high‑risk problem with certain Compact Medical ButterflyBVM bag‑valve‑mask devices. Compact Medical…
    fda medwatch · 6d agoCRLNegative↗ source
  • MGB CEO's vague email on financial challenges fuels anxiety after recent layoffs
    Mass General Brigham chief executive Dr. Anne Klibanski emailed the system’s roughly 85,000 staff late Monday, warning of urgent financial challenges and a need to improve performance. The message…
    STAT · 5d agoLayoffsNegative↗ source
  • 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
  • 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
  • Legal experts advise European healthcare manufacturers on navigating complex environmental regulations
    At the RAPS Regulatory Intelligence Conference Europe in Barcelona, two legal specialists highlighted the difficulty of Europe’s environmental and sustainability rules for companies that make healt…
    raps · 6d agoRegulatoryNeutral↗ source
  • FDA reports rise in unannounced drug inspections in China and India for FY 2026
    A senior FDA enforcement official said the agency carried out more surprise drug facility inspections in India and China during fiscal year 2026 than it did in the prior year. The unannounced visi…
    raps · 6d agoRegulatoryNeutral↗ 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
  • Stakeholders submit over 500 comments urging FDA to shape regulation of generative AI medical devices
    Over 500 comments have been filed in response to the FDA's discussion paper on generative AI-enabled medical devices. The feedback reflects a wide range of viewpoints. Some participants recommend…
    raps · 6d agoRegulatoryNeutral↗ 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
  • Recon: Merck KGaA to exit CDMO business; Karyopharm to sell itself in bankruptcy
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 6d ago↗ 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