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3,183 stories matching this filter · ← front page

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  • 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
  • Kyverna reports positive one-year CAR-T results for rare stiff person syndrome, supporting FDA filing
    Kyverna Therapeutics announced that its CAR-T therapy for stiff person syndrome showed positive results after one year of treatment. The trial involved patients with the rare autoimmune disorder,…
    Endpoints · 27d agoPositive readoutPositive↗ 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 · 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 · 28d 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
  • Elevar Therapeutics receives FDA approval for Lyrfigtu as second-line treatment for bile duct cancer
    The U.S. Food and Drug Administration has approved Elevar Therapeutics' drug Lyrfigtu as a second‑line option for patients with bile duct cancer who meet specific criteria. Bile duct cancer is dia…
    Endpoints · 27d agoApprovalPositive↗ 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
  • AI doomsday warnings may curb health-tech innovation, Epic cautions
    Recent commentary warns that sensational AI doomsday predictions could slow the pace of health‑technology innovation. Epic, the large electronic health‑record company that provides AI tools to hos…
    Endpoints · 27d agoNegative↗ 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
  • Sarepta Therapeutics agrees to pay $39 million to settle gene therapy dispute with Regenxbio
    Sarepta Therapeutics has agreed to resolve a dispute with Regenxbio by paying $39 million. The payment settles claims related to gene therapy technology that both companies have been developing.…
    Endpoints · 27d agoDealNeutral↗ source
  • Heidi Overton, Trump’s FDA commissioner nominee, to face Senate confirmation hearing
    Heidi Overton has been nominated by President Donald Trump to serve as the next commissioner of the U.S. Food and Drug Administration. She is scheduled to appear before the Senate Health, Educatio…
    Endpoints · 27d 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
  • Galil Importing Corp recalls Lior ground cinnamon over elevated lead levels
    Galil Importing Corp of Hauppauge, New York announced a recall of its Lior Cinnamon Ground Seasoning because of potential elevated lead contamination. The product, distributed to retail outlets in…
    fda recalls · 27d agoRegulatoryNegative↗ source
  • Deano’s Pasta recalls 20 lbs of ravioli over undeclared lobster allergen
    Deano’s Pasta of Somerville, Massachusetts announced a recall of its Pear and Pecorino Triangoli Ravioli after discovering the product may contain undeclared lobster, a crustacean shellfish allerge…
    fda recalls · 27d agoRegulatoryNegative↗ 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
  • FDA approves Eli Lilly's once-weekly insulin pen, setting up rivalry with Novo
    Eli Lilly’s once-weekly basal insulin shot Onswik has been approved by the FDA for patients with type 2 diabetes. Lilly has touted Onswik as a longer-acting alternative to daily basal insulin injec…
    Endpoints · 27d ago↗ source