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  • FDA digital chief signals upcoming AI regulatory guidance
    STAT+ health-tech newsletter reported that the FDA’s digital leader offered a preview of forthcoming guidance on artificial intelligence. The briefing, delivered by Rick Abramson, highlighted the a…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Half of U.S. states file lawsuits challenging Medicaid work-requirement rules
    A coalition of states has filed legal challenges against recent Medicaid work‑requirement policies, arguing that the rules threaten access to health coverage for low‑income residents. The lawsuits…
    STAT · 1mo agoRegulatoryNegative↗ source
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  • Trump administration downplays alcohol risks, hindering efforts to curb drinking-related harms
    A STAT investigation reported that the Trump administration has downplayed the health risks of alcohol and has taken steps that obstruct research into drinking-related harms. Although alcohol is r…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Rep. Tom Kean Jr. Discloses Depression Diagnosis After Four-Month Congressional Absence
    Rep. Tom Kean Jr., a Republican congressman from New Jersey, announced on the House floor that he has been receiving treatment for depression, which explains his unexplained four-month absence from…
    STAT · 1mo agoNeutral↗ source
  • Florida mandates EKGs for high-school athletes, but the new law may cause stress and cost
    Florida has become the first state to require electrocardiograms for high‑school athletes before they can participate in sports. The law is intended to screen for hidden heart conditions that could…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Student loan cap policy favors chiropractic over critical health professions, warns surgeon
    David S. Shapiro, a board-certified surgeon and physician executive, argues that the Education Department's new student-loan limits miss the realities of modern health care. The rule caps annual f…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 1mo agoNeutral↗ source
  • 26 states file lawsuit to halt federal Medicaid work-requirement rule
    Five New England states joined 21 others in a lawsuit filed Monday to stop a federal rule that would add work requirements to Medicaid. The states argue the new guidelines create an unfair bureaucr…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA adds peptide-focused physicians to advisory panel, raising conflict-of-interest concerns
    The FDA announced eight new members for a committee that will advise on whether compounding pharmacies can produce certain peptides. Most of the appointees are physicians or pharmacists who run bu…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • 5 takeaways from STAT’s investigation into microhospital operator Nutex Health
    Read the takeaways from STAT's investigation into Nutex, which used the No Surprises Act to fuel a stunning financial turnaround.
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA’s top gene-therapy regulator Vijay Kumar steps down amid leadership shake-up
    Vijay Kumar, the acting director of the FDA office that reviews cell and gene therapies, has announced he will leave his position. In an email to staff, Kumar said he reflected on his tenure and de…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • AstraZeneca to Pay $34 Million Settlement Over Texas Medicaid Kickback Allegations
    AstraZeneca has agreed to a $34 million settlement with the Texas attorney general over allegations that it provided improper incentives to boost prescriptions covered by Texas Medicaid. The state…
    STAT · 1mo agoRegulatoryNegative↗ source
  • California hospital lawsuits reveal forced McKinsey ties and surprise ER chain profits
    Unredacted comments from recent California hospital lawsuits show that hospital executives admitted to a "forced" partnership with consulting firm McKinsey, raising questions about the influence of…
    STAT · 1mo agoRegulatoryNegative↗ source
  • European regulators give second chance approval to Acadia’s Daybu for Rett syndrome
    European Medicines Agency's CHMP has reversed its earlier negative vote and now recommends marketing authorization for Acadia Pharmaceuticals' drug Daybu (trofinetide) for Rett syndrome. The posit…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • FDA accepts resubmission of Replimune’s RP1 cancer therapy, decision due Aug. 2; Merck KGaA announces $11 B life-sciences spend
    The U.S. Food and Drug Administration has accepted Replimune's resubmitted application for its cancer drug RP1, with a final decision slated for August 2 and an advisory committee meeting planned f…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • US biotech faces regulatory push as China licensing deals spark security concerns
    A surge in licensing agreements between Chinese pharmaceutical firms and U.S. biotech companies has been noted, with nearly 100 deals announced since early 2025, prompting worry among investors and…
    BioPharma Dive · 2mo agoRegulatoryNegative↗ source
  • Alkermes CEO targets orexin market after strong narcolepsy pill data
    Alkermes' incoming chief executive outlined a strategy to compete with larger rivals in the emerging orexin drug class. Recent mid-June trial results showed the experimental oral compound alixorex…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • La Ceiba Foods recalls Salvadoran and Mexican cottage cheese over possible Listeria contamination
    La Ceiba Foods Latin Market Inc. announced on June 26, 2026 that it is recalling its Requesón Salvadoreño (Salvadoran cottage cheese) and Requesón Mexicano (Mexican cottage cheese) products sold un…
    fda recalls · 2mo agoRegulatoryNegative↗ source
  • STAT readers split on spelling of "health care" as industry leans toward single word
    STAT recently asked its audience whether to write the term as two words or one. Roughly 60% of respondents favored one spelling over the other. The discussion highlights a subtle but growing trend…
    STAT · 2mo agoNeutral↗ source
  • Opinion: STAT readers debate blue zones, open-access publishing fees, and more
    Keep those letters coming!
    STAT · 2mo ago↗ source
  • STAT+: Up and down the ladder: The latest comings and goings
    From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
    STAT · 2mo ago↗ source
  • Opinion: Maternity deserts aren’t accidents. They’re the result of a design flaw
    Shrinking fertility should mean less strain on doctors. But nearly half of U.S. counties lack a practicing obstetrician or gynecologist.
    STAT · 2mo ago↗ source
  • Opinion: STAT+: The real work for making dramatic gains against pancreatic cancer is just beginning
    The co-founders of Darwin Health write that the real work for making dramatic gains against pancreatic cancers is just beginning.
    STAT · 2mo ago↗ source
  • Tennessee pharmacies sell potent ivermectin, led by anti-vaccine doctor who’s taken ‘bucketloads’
    Tennessee pharmacies are selling potent versions of the antiparasitic drug ivermectin, led by an anti-vaccine doctor who’s taken "bucketloads."
    STAT · 2mo ago↗ source