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  • Industry groups urge FDA to add clarity and flexibility to manufacturer-payor communication guidance
    Industry associations and other stakeholders have asked the U.S. Food and Drug Administration to give more detail and flexibility in its updated guidance on how drug and device makers talk with pay…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FTC launches antitrust probe into Epic Systems over alleged anticompetitive practices
    Federal Trade Commission investigators have reached out to at least three people as part of a broad inquiry into Epic Systems' business practices. Epic, the nation's largest electronic health reco…
    STAT · 2mo agoRegulatoryNegative↗ source
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  • Methadone clinics show mixed progress two years after regulatory overhaul
    In 2024 the federal government revised rules for opioid addiction treatment centers, giving them more leeway to provide take‑home methadone doses and removing the requirement that patients attend c…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • UnitedHealthcare CEO Brian Thompson killed; suspect Luigi Mangione pleads guilty to federal stalking
    Luigi Mangione, 28, pleaded guilty in Manhattan federal court to stalking charges tied to the 2024 killing of UnitedHealthcare chief executive Brian Thompson. He told the court he followed Thompso…
    STAT · 2mo agoNegative↗ source
  • FDA issues final guidance on formal meeting types and timelines for drug and biologics sponsors
    The U.S. Food and Drug Administration released final guidance on August 13 that details the types of formal meetings sponsors can request during the development of new drugs and biologics. The doc…
    raps · 2mo agoRegulatoryNeutral↗ source
  • US and UK health systems both prioritize clinical care over community prevention, author warns
    Kyle Vanelli argues that the United States and United Kingdom health systems share a fundamental flaw: they default to biomedical, hospital-based interventions rather than community-based preventiv…
    STAT · 2mo agoNegative↗ source
  • CMS rule blocks Medicaid funding for pediatric gender-affirming care, raising legal challenges
    The Centers for Medicare and Medicaid Services finalized a rule that prohibits the use of Medicaid and CHIP dollars to cover pediatric gender‑affirming medications and surgeries. Previous attempts…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Exotique Foods recalls Momchipz Veggie Chips for possible undeclared gluten
    Exotique Foods Inc of Ontario announced a recall of its Momchipz Veggie Chips in the broccoli florets and cauliflower flavor because the product may contain undeclared gluten. The chips, sold in 3…
    fda recalls · 2mo agoCRLNegative↗ source
  • Pediatricians push back against vaccine fear-mongering by federal leaders
    Andrew D. Racine, president of the American Academy of Pediatrics, writes an opinion piece warning that federal leaders are spreading misleading claims about vaccines, creating confusion for parent…
    STAT · 2mo agoNegative↗ source
  • FDA releases weekly update on user fee letters and new HHS regulatory agenda
    The FDA's latest weekly briefing highlighted the release of user fee commitment letters, which outline the agency's financial planning for upcoming fiscal periods. It also introduced a new regulat…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Formation Bio appoints Michael Ehlers as chief scientific officer and head of R&D
    Formation Bio announced the hiring of Michael Ehlers as its new chief scientific officer and head of research and development. Ehlers brings experience from founding and leading Ascidian Therapeut…
    STAT · 2mo agoPositive↗ source
  • The Hampton Grocers recalls 8-oz Lacnola Lactation Granola over possible Salmonella contamination
    The company announced a recall of its 8-oz Lacnola Lactation Granola due to potential Salmonella contamination. The product was sold nationwide through the company's website and other online retai…
    fda recalls · 2mo agoRegulatoryNeutral↗ source
  • Exotique Foods recalls Momchipz Veggie Chips over undeclared wheat risk
    Exotique Foods Inc announced a recall of its Momchipz Veggie Chips Broccoli Florets & Cauliflower because the product may contain undeclared wheat, posing a serious allergy risk. The chips, sold t…
    fda recalls · 2mo agoCRLNegative↗ source
  • Opinion: Car telematics warns of health-insurance data surveillance
    Sociologists Andréa Becker and Paul Kamuf argue that the telematics model used in auto insurance could become a template for health‑insurance data collection. They describe how drivers’ minute‑by‑…
    STAT · 2mo agoNegative↗ source
  • Neurocrine’s rare-disease drug approved but later linked to deaths and serious side effects
    Neurocrine Biosciences received regulatory approval for a rare‑disease therapy after a small clinical trial showed modest efficacy and side effects that were considered manageable. The decision was…
    STAT · 2mo agoRegulatoryNegative↗ source
  • California distributes over 120,000 low-cost insulin glargine packs as Novo Nordisk CEO warns investors on obesity drug differentiation
    California's state health program has been distributing a low-cost insulin glargine product, more than 120,000 five-pen packs since its launch seven months ago. Each pack is priced at $55, which i…
    STAT · 2mo agoNeutral↗ source
  • Oxford study offers model showing statins pose minimal muscle disorder risk, a tool against health misinformation
    The piece highlights how fearmongering about statins has surged online, with claims that the drugs damage the brain, liver and muscles. The authors argue that clearer evidence at the point of claim…
    STAT · 2mo agoPositive↗ source
  • Vaccines protect lives: A physician’s reminder of what we lose without them
    Dr. Krutika Kuppalli, an infectious-disease physician and former WHO medical officer, reflects on her frontline work where vaccines were scarce. In Haiti she witnessed a patient die from tetanus,…
    STAT · 2mo agoPositive↗ source
  • Medicare's new add-on payments for AI devices may spur hospital adoption and risk overuse
    Medicare has begun paying hospitals extra fees for using newly authorized AI-based medical devices, known as technology add-on payments, for a limited period after market entry. The payments are i…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • FDA schedules hearing on Concerta generic withdrawal as Ivonescimab secures first-line lung cancer indication in China
    The U.S. Food and Drug Administration has granted a hearing to consider the withdrawal of a generic version of Concerta. The hearing will address regulatory concerns surrounding the product. In Ch…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Eli Lilly moves to curb black-market sales of retatrutide amid rising illicit demand
    Eli Lilly announced steps to address the growing black‑market trade of its obesity/diabetes drug retatrutide, which has seen increasing illicit use. The company is working with law‑enforcement and…
    STAT · 2mo agoRegulatoryNegative↗ source
  • New fertility options give young cancer survivors hope for parenthood
    Young cancer patients are facing increasing concerns about future fertility, prompting the growth of a specialty called oncofertility that blends oncology and reproductive medicine. One patient, J…
    STAT · 2mo agoPositive↗ source
  • STAT+ probes Commure’s AI-driven health-care platform and Medicare’s new incentives for AI medical devices
    The STAT Health Tech newsletter edition dated Aug 13, 2026 features an investigative piece on Commure, a General Catalyst-backed firm that claims to automate health-care operations using artificial…
    STAT · 2mo agoNeutral↗ source
  • California’s new CalRx insulin label aims for affordable access but faces slow rollout
    California launched a state‑branded insulin label, CalRx, this year to provide lower‑cost insulin to patients without insurance. The pens, marked with the state’s grizzly bear logo, are now stocked…
    STAT · 2mo agoNeutral↗ source
  • European trade group urges authorities to grant notified bodies access to Eudamed for risk-based oversight
    A trade association representing notified bodies has formally asked EU regulators to allow them to access the Eudamed database. The group says that such access would enable them to apply the risk-…
    raps · 2mo agoRegulatoryNeutral↗ source