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2,759 stories matching this filter · ← front page

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  • 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 · 1mo 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 · 1mo agoPositive↗ source
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  • 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoNeutral↗ source
  • FDA nominee Overton parries vaccine questions at Senate hearing
    Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research.
    BioPharma Dive · 1mo ago↗ source
  • FDA nominee Heidi Overton pledges faster drug trials to keep US biotech competitive
    Heidi Overton, President Trump's nominee for FDA commissioner, will appear before a Senate committee to outline her priorities for the agency. She said the administration wants her to 'go fast,' a…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Roche and Ionis report positive Phase 3 interim results for IgA nephropathy drug sefaxersen
    Roche and Ionis announced that their experimental RNA therapy sefaxersen met its primary endpoint in an interim analysis of a Phase 3 trial for IgA nephropathy. The trial showed statistically sign…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • European pharma CEOs warn of biotech decline as R&D share drops to 31% and call for faster trials and stronger IP protection
    Nine leading European pharma board chairs issued an open letter warning that Europe is losing its biotech edge. They note that Europe's share of global pharma R&D fell from 43% in 1990 to 31% toda…
    BioPharma Dive · 1mo agoNegative↗ source
  • FDA advisory panel backs Grail's Galleri multi-cancer blood test, citing benefits outweigh risks
    The Food and Drug Administration’s advisory committee voted to endorse Galleri, a blood test from Grail that screens for multiple cancers, saying the benefits outweigh the risks. The panel’s vote…
    STAT · 1mo agoRegulatoryPositive↗ source
  • AI-driven biotech Enveda secures $311 million Series E to advance plant-derived drug candidates
    Enveda Biosciences, a Colorado AI drug discovery company, announced a $311 million Series E financing round, one of the larger biotech raises this year. The firm uses artificial intelligence to sc…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Flagship Pioneering secures Pentagon contract to develop biological threat countermeasures
    Flagship Pioneering, a biotech investment firm, has been awarded a contract by the U.S. Department of Defense. The contract aims to advance technologies that can serve as countermeasures against b…
    STAT · 1mo agoDealPositive↗ source
  • US HHS and FDA announce new rules to expand non-animal testing methods as legal battles over youth gender-affirming care continue
    The legal landscape for youth gender‑affirming care remains turbulent, with the Trump administration's aggressive stance prompting dozens of hospitals nationwide to halt such services, even in the…
    STAT · 1mo agoRegulatoryNeutral↗ source