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  • Federal judge overturns key disability protection law
    A federal judge has reversed a longstanding disability protection ruling, reducing the legal safeguards that favored community-based living over institutional care. The Justice Department had anno…
    STAT · 26d agoRegulatoryNegative↗ source
  • Opinion: FDA commissioner nominee Heidi Overton is ignoring the science on abortion drug
    “With this latest appointment, mifepristone has a new boss but an old problem,” writes Julie F. Kay, founder and CEO of Reproductive Futures.
    STAT · 26d ago↗ source
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STAT+: Pharmalittle: We’re reading about a reticent FDA commish nominee, a Novo deal, and more
President Trump’s nominee to lead the FDA was grilled by senators on hot button topics like China, vaccines, and abortion access
STAT · 26d ago↗ source
  • Heidi Overton, a New Mexico-born physician, nominated as FDA commissioner
    Heidi Overton grew up in Gallup, New Mexico, and as a college freshman expressed a desire to become a doctor and return to her small hometown. Her early ambition was highlighted in a 2007 intervie…
    STAT · 27d agoRegulatoryPositive↗ source
  • FDA nominee Heidi Overton avoids taking positions in Senate hearing on vaccines, China and abortion
    Heidi Overton, President Trump’s pick to lead the Food and Drug Administration, appeared before the Senate health committee for a two hour hearing. Senators focused their questions on China, vaccin…
    STAT · 27d agoRegulatoryNegative↗ source
  • Indonesian court strikes down patent evergreening amendment, signaling pushback on drug pricing tactics
    An Indonesian Constitutional Court ruled that a recent amendment allowing patent evergreening was unconstitutional, reinstating the original restriction that balances patent rights with public heal…
    STAT · 27d agoRegulatoryPositive↗ source
  • Kyverna reports durable responses in early cell therapy trial for autoimmune disease
    Kyverna Therapeutics announced new data from its cell therapy candidate targeting an autoimmune condition, marking progress toward a potential first‑in‑class product. The results showed that a not…
    STAT · 27d agoPositive readoutPositive↗ source
  • FDA nominee Heidi Overton pledges faster, more efficient regulation to keep pace with China
    During a Senate hearing, Heidi Overton was confirmed as the nominee to lead the U.S. Food and Drug Administration. She outlined her priorities for the agency. Overton said the FDA must move faster…
    STAT · 27d agoRegulatoryNeutral↗ source
  • Gilead pushes further into immunology, touts inflammation drug pipeline
    Gilead Sciences’ senior leadership has repeatedly emphasized the company’s long‑term ambition to expand beyond its virology roots into the inflammatory and autoimmune space. The messaging, delivere…
    STAT · 27d agoPositive↗ source
  • Novartis and Novo Nordisk trials lower biomarkers but fail to cut heart events, prompting preventive cardiology rethink
    The article discusses two recent Phase 3 trials that achieved their biological goals but did not improve clinical outcomes. Novartis reported that pelacarsen in the Lp(a) HORIZON study successfull…
    STAT · 27d agoNegative readoutNegative↗ source
  • Heidi Overton, Trump’s FDA nominee, to appear before Senate committee for confirmation hearing
    Heidi Overton, a 37‑year‑old preventive‑medicine physician, is the Trump administration’s pick to lead the Food and Drug Administration and will face a Senate committee this morning. Lawmakers hav…
    STAT · 27d agoRegulatoryNeutral↗ source
  • Congress mulls linking Medicare doctor pay to medical inflation under Patients First Act
    Congress is debating a major overhaul of Medicare physician payments, proposing to tie rates to a medical inflation index. The plan, part of the Patients First Act, would give doctors automatic an…
    STAT · 27d agoRegulatoryNeutral↗ source
  • Abiomed issues recall of Automated Impella Controllers over purge cassette detection issue
    Abiomed has announced a recall of its Automated Impella Controllers after identifying failures in the purge cassette recognition system, which could lead to prolonged delays in mechanical circulato…
    fda medwatch · 27d agoRegulatoryNegative↗ source
  • Senators question FDA nominee as agency issues rule to cut animal testing
    The latest FDA briefing highlighted two key developments: a Senate hearing on the agency’s next leader and a new regulation targeting animal testing. During the confirmation hearing, senators pres…
    raps · 28d agoRegulatoryNeutral↗ source
  • FDA signals need for GCP compliance to accept foreign clinical trial data for regulatory review
    The U.S. Food and Drug Administration says it will only consider clinical evidence generated outside the United States if the studies were conducted according to good clinical practice standards.…
    raps · 28d agoRegulatoryNeutral↗ source
  • STAT's The Readout LOUD podcast goes international with a Shanghai dispatch on China's biotech surge
    The Readout LOUD podcast, part of STAT's weekly biotech series, is expanding its reach beyond the United States this week. Host Jason Mast reports from Shanghai, where he examines how China's growi…
    STAT · 27d agoNeutral↗ source
  • Senate Finance Committee Advances Chris Klomp’s HHS Deputy Nomination
    The Senate Finance Committee voted Thursday to move Chris Klomp’s nomination for deputy secretary of the Department of Health and Human Services forward to the full Senate. The 15-12 vote saw all…
    STAT · 27d agoRegulatoryNeutral↗ source
  • Measles deaths rise as U.S. sees worst outbreak since 1991, CDC reports four fatalities in Pennsylvania
    The Centers for Disease Control and Prevention has added a measles death to its online counter, highlighting a recent increase in fatalities. State officials in Pennsylvania say four unvaccinated…
    STAT · 27d agoNegative↗ source
  • Physician who survived measles warns of rising U.S. cases and deaths
    Jewel Mullen, an associate professor at Dell Medical School, recalls surviving a near-fatal measles infection as a kindergartener in 1961, before a vaccine existed. Her personal ordeal and decades…
    STAT · 27d agoNegative↗ source
  • Radiology practices increasingly develop and market in-house AI, branding themselves as AI-native
    Radiology groups, especially outpatient and teleradiology firms, are moving beyond using third‑party AI tools and are building their own algorithms within the practice. By keeping development in‑h…
    STAT · 27d agoPositive↗ source
  • EMA leaders say single pivotal trial should not be default, decision must match evidence needed
    EMA chief Emer Cooke and other officials weighed in on the ongoing debate about the number of pivotal trials required for drug approval. They argued that requiring a single pivotal trial as a rigi…
    raps · 28d agoRegulatoryNeutral↗ source
  • Trump administration claims all states will join Medicaid drug pricing program, but several states remain undecided
    White House officials announced that every U.S. state had agreed to participate in a new federal Medicaid drug pricing initiative, describing it as a "good deal" for states. State officials, howev…
    STAT · 27d agoRegulatoryNeutral↗ source
  • Senators Question FDA Nominee Overton as Agency Issues New Rule to Cut Animal Testing
    Senators on the Senate Health Committee interrogated President Trump's nominee to lead the FDA, Dr. Janet Overton, during her confirmation hearing. Lawmakers focused on her views about the agency's…
    raps · 28d agoRegulatoryNeutral↗ source
  • Senate grills Trump’s FDA nominee Heidi Overton on agency priorities
    Heidi Overton, President Trump’s nominee to lead the U.S. Food and Drug Administration, appeared before the Senate for a confirmation hearing on September 24, 2026. Senators from both parties aske…
    raps · 28d agoRegulatoryNeutral↗ source
  • Radiology startups say owning clinics speeds AI tool development as insurers resist new RPM rules
    Radiology startups argue that owning their own imaging practices gives them direct access to patient scans and workflow data, which they say accelerates the creation and testing of artificial‑intel…
    STAT · 27d agoNeutral↗ source