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  • FDA releases proposed commitment letter detailing changes to GDUFA IV program
    The U.S. Food and Drug Administration has issued a proposed commitment letter for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA IV). The letter follows several months o…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Vaping and cannabis use hit record highs among U.S. young adults in 2025, survey finds
    A new national survey by the University of Michigan shows vaping and cannabis use among U.S. young adults reached record levels in 2025. Past‑30‑day nicotine vape use rose to 19%, more than triple…
    STAT · 1mo agoNegative↗ source
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  • Postpartum psychiatry remains inadequately understood, case of Lindsay Clancy highlights gaps
    The opinion piece, authored by a neuroscience professor at Tufts, an obstetrics‑psychiatry specialist at NewYork‑Presbyterian and Weill Cornell, and a psychiatry researcher at the University of Vir…
    STAT · 1mo agoNegative↗ source
  • Renowned autoimmune researcher Georg Schett co-founds biotech to develop antibody therapies
    Georg Schett, a German scientist noted for pioneering CAR‑T approaches in autoimmune disease, is now launching a new biotech venture. The startup, which has not yet been named in the report, will…
    STAT · 1mo agoDealPositive↗ source
  • Inside a Secret AI Startup: Challenges of Building and Selling Clinical Tools
    The STAT+ newsletter reveals that a health‑tech reporter has been quietly developing an artificial‑intelligence startup for the past six months. The piece describes the difficulties of rapidly cre…
    STAT · 1mo agoNeutral↗ source
  • Medicaid to End Funding for Gender-Affirming Surgeries and Hormone Therapy for Transgender Youth
    The Trump administration announced that Medicaid will no longer cover gender-affirming surgeries and hormone treatments for minors. The change also applies to the Children’s Health Insurance Progr…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Health industry pushes back against Trump’s vaccine executive order
    President Trump signed an executive order this week that would overhaul the federal childhood‑vaccination program, calling for fewer shots administered over a longer period. The order specifically…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Experts warn splitting MMR vaccine into separate shots could increase missed doses and illness
    The article notes that a recent executive order proposes separating the combined measles, mumps and rubella vaccine into three individual injections. The author argues that this change could lead t…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Medicare’s new $50 GLP‑1 weight‑loss drug program may create barriers for patients, warns experts
    Medicare has launched a program that caps out‑of‑pocket costs for GLP‑1 weight‑loss medicines such as Wegovy, Zepbound and Foundayo at $50 a month for eligible beneficiaries. The initiative is inte…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg injection vials over glass particle contamination
    Fresenius Kabi announced a recall of a specific lot of its Tyenne (tocilizumab-aazg) injection, 400 mg/20 mL vials, after detecting glass particles in the product. The company said the contaminati…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Trump’s vaccine executive order likely erodes public trust, says epidemiologist
    President Trump signed an executive order that claims to restore confidence in childhood vaccines by scaling back state mandates and trimming the recommended schedule from 18 diseases to 11. The o…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Trump pushes controversial changes to MMR vaccine policy, eclipsing new food additive rule
    President Trump has shifted the national conversation back to vaccine policy, calling for the measles‑mumps‑rubella (MMR) vaccine to be broken up into separate shots. The proposal has sparked immed…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA rejects ITM Isotope's radiopharmaceutical therapy over manufacturing problems, halting potential competitor to Novartis
    The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich SE, citing manufacturing deficiencies. The therapy was desig…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Skylark Bio launches first-in-human gene therapy trial targeting deafness
    Skylark Bio, which has operated in stealth, announced that it has dosed the first patient in a gene-therapy trial aimed at treating hearing loss. The study marks the company's entry into the emergi…
    STAT · 1mo agoPositive↗ source
  • French study finds stopping statins in low-risk adults over 75 does not raise mortality
    A new French non-inferiority study published in Lancet Healthy Longevity examined whether discontinuing statin therapy in people older than 75 who have no prior cardiovascular disease would affect…
    STAT · 1mo agoPositive readoutNeutral↗ source
  • Nurses voice concerns on AI while regulators outline RAPID pathway for breakthrough devices
    The latest STAT Health Tech newsletter, dated August 11, 2026, highlights two contrasting developments in health technology. Nurses interviewed for the piece express skepticism about the impact of…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Nonprofit North Star Review Board offers independent model to fix IRB oversight issues
    Founders Stephen Rosenfeld and Patricia Seymour created the not‑for‑profit North Star Review Board after becoming disillusioned with the current system of institutional review boards (IRBs) that ov…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Nurses push for involvement as AI threatens jobs and patient care
    Nurses, the largest segment of the health‑care workforce, are increasingly vocal about the risks that clinical artificial intelligence poses to their employment and to patient safety. At Montefior…
    STAT · 1mo agoNegative↗ source
  • MoonLake Immunotherapeutics’ vague data on its autoimmune candidate draws criticism
    Adam Feuerstein notes that MoonLake Immunotherapeutics announced "positive" results for its autoimmune drug candidate but released data that is difficult to interpret. He reminds readers that biot…
    STAT · 1mo agoNegative↗ source
  • FDA rejects ITM radiopharma therapy while WHO defends immunization schedules
    The U.S. Food and Drug Administration has issued a rejection of a radiopharmaceutical therapy identified as ITM, indicating that the product did not meet the agency's requirements for approval. Th…
    raps · 1mo agoRegulatoryNeutral↗ source
  • PIC/S releases revised guide on qualification and validation studies for pharma manufacturing
    PIC/S has issued an updated guideline that outlines general principles for qualification and validation studies in pharmaceutical manufacturing facilities. The new guide is intended for both inspe…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Abortion care shifts to remote and private channels as patients seek help outside clinics
    Patients are increasingly turning to non‑clinical avenues for abortion information, a trend that began before the Dobbs decision. A family physician recounts a recent encrypted message from a teena…
    STAT · 1mo agoNeutral↗ source
  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 1mo agoNegative readoutNegative↗ source