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392 stories matching this filter · ← front page

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  • Global liver experts agree on definition of acute-on-chronic liver failure
    Liver doctors from many countries have reached a common definition for acute-on-chronic liver failure, a serious complication that occurs when an existing liver disease is suddenly worsened by an a…
    STAT · 1d agoPositive↗ source
  • FDA grants accelerated approval to J&J's Rybrevant for recurrent head and neck cancer
    The U.S. Food and Drug Administration has issued an accelerated approval for Johnson & Johnson's antibody-drug conjugate Rybrevant targeting head and neck cancers that have returned after prior che…
    Endpoints · 3d agoApprovalPositive↗ source
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Nephrology758
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 4d agoApprovalPositive↗ source
  • Medicare to slash 340B drug payments and expand site-neutral rules in 2027
    Medicare finalized a rule that will cut payments for drugs covered by the 340B discount program and broaden site-neutral payment policies beginning in 2027. The rule is expected to reduce Medicare…
    BioPharma Dive · 4d agoRegulatoryNegative↗ source
  • J&J and AbbVie present early trispecific antibody data for multiple myeloma at ASH meeting
    At the American Society of Hematology (ASH) meeting, Johnson & Johnson and AbbVie are slated to share early clinical data on trispecific antibodies targeting multiple myeloma. These next‑generation…
    BioPharma Dive · 4d agoPositive readoutPositive↗ source
  • UniQure slated for FDA decision by May 1 as analysts see potential for first Huntington’s disease therapy
    UniQure said the Food and Drug Administration has set a decision date for its Huntington's disease gene therapy and is likely to hold an advisory committee meeting. The agency indicated a faster‑th…
    BioPharma Dive · 6d agoRegulatoryNeutral↗ source
  • Kymera Therapeutics to unveil mid‑stage eczema trial data, aiming to challenge Dupixent
    Kymera Therapeutics, a Massachusetts‑based biotech, is set to release data from its mid‑stage clinical trial of KT‑621 in eczema before the end of 2026. The trial results are being closely watched…
    STAT · 8d agoPositive readoutNeutral↗ source
  • Washington resident dies after bird flu infection linked to dairy cattle exposure
    A resident of Yakima County, Washington, died from complications of avian influenza after being exposed to infected cattle at a dairy farm. Health officials said the infection was the H5N1 strain,…
    STAT · 7d agoNegative↗ source
  • CinRx partners with Graviton Bioscience to target ROCK2 in pulmonary arterial hypertension and other cardiovascular diseases
    CinRx announced a collaboration with Graviton Bioscience, led by Sam Waksal, to develop therapies that inhibit the ROCK2 enzyme. The partnership will focus on pulmonary arterial hypertension (PAH)…
    Endpoints · 7d agoDealNeutral↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 10d agoApprovalPositive↗ source
  • Lilly beats forecasts and raises outlook as Novartis steadies and GSK faces investor pressure
    Lilly reported third‑quarter revenue that exceeded analysts' expectations by about 8%, driven by strong demand for its diabetes and obesity treatments Mounjaro and Zepbound. The company also lifted…
    BioPharma Dive · 10d agoEarningsPositive↗ source
  • Setara Biosciences launches with $90 million to pursue Charcot-Marie-Tooth and other rare-disease therapies
    Setara Biosciences announced its formation on Friday, backed by $90 million of financing to advance a pipeline of experimental medicines. The company’s first candidate targets the genetic disorder…
    BioPharma Dive · 11d agoDealPositive↗ source
  • Podcast examines Merck and Moderna’s mRNA cancer vaccine data presented at ESMO
    The latest episode of STAT’s biotech podcast "The Readout LOUD" focused on the mRNA cancer vaccine being co‑developed by Merck and Moderna, using data shown at the European Society for Medical Onco…
    STAT · 10d agoNeutral↗ source
  • 1834 measles letter highlights historic roots of today's anti-vaccine sentiment
    Jim Downs, a medical historian, examined a 1834 letter from Jane Butt in a London journal while at Yale's medical library, noting the date matches 192 years later. Butt described a measles outbrea…
    STAT · 11d agoNeutral↗ source
  • FDA drafts guidance to speed approvals of individualized gene therapies, hailed as win for rare disease patients
    The U.S. Food and Drug Administration released draft guidance aimed at streamlining the approval process for certain individualized gene therapies. The proposal would allow sponsors to avoid filing…
    STAT · 12d agoRegulatoryNeutral↗ source
  • Eli Lilly to merge U.S. and international units after exec retirement; Novartis records $1.9B impairment on failed Avidity drug
    Eli Lilly announced that its U.S. and international divisions will be combined into a single unit called "Lilly Global Markets" after the retirement of long‑time executive Patrik Jonsson at the end…
    BioPharma Dive · 12d agoNeutral↗ source
  • Lawmaker asks GAO to examine TrumpRx claims of $700 million drug savings
    Representative Frank Pallone, the ranking member of the House Energy and Commerce Committee, sent a letter to the Government Accountability Office asking it to assess whether the TrumpRx website ha…
    STAT · 12d agoRegulatoryNegative↗ source
  • Phase 3 trial shows cancer vaccine intismeran autogene cuts recurrence risk by 42% versus Keytruda
    At the European Society for Medical Oncology Congress, a Phase 3 trial of the personalized cancer vaccine intismeran autogene reported a 42% reduction in risk of recurrence or death compared with p…
    STAT · 14d agoPositive readoutPositive↗ source
  • U.S. judge denies effort to block Eli Lilly's weight-loss ad; GSK reports oncology drug approval
    A U.S. district judge rejected a request to halt Eli Lilly's advertising campaign that Novo Nordisk alleges is deceptive in promoting its weight‑loss medicines. Novo Nordisk argued the ads could m…
    STAT · 13d agoRegulatoryNeutral↗ source
  • Pennsylvania Mennonite community creates its own biotech firm after successful gene therapy in a calf with maple syrup urine disease
    A tight‑knit Mennonite community in Lancaster County, Pennsylvania, has long faced a high rate of maple syrup urine disease (MSUD), a rare genetic disorder that can be fatal. With few external biot…
    STAT · 14d agoPositive↗ source
  • Missouri AG orders Eli Lilly to stop demanding hospital data for 340B discounts
    Missouri Attorney General Catherine Hanaway sent a cease‑and‑desist letter to Eli Lilly on Oct 26, demanding the company stop requiring hospitals to submit claims data as a condition for receiving…
    STAT · 13d agoRegulatoryNegative↗ source
  • Nonprofit revives gene therapy program after UK startup closure
    Bloomsbury Genetic Therapies, a U.K.-based gene‑therapy startup, announced it was shutting its doors after treating only a single patient. The company’s closure left its lead experimental therapy w…
    STAT · 13d agoPositive↗ source
  • Researchers isolate marine compound that may halt deadly brain-eating amoeba infections
    Brain-eating amoebas are notoriously difficult to treat and have a mortality rate that is almost 100%. The article notes that researchers have now isolated a compound from the sea that could potent…
    STAT · 13d agoPositive↗ source
  • RFK Jr. campaigns in Iowa as healthcare companies prepare earnings reports
    Robert F. Kennedy Jr. appeared in Iowa to support GOP gubernatorial candidate Zach Lahn, marking his final push on the campaign trail. The week’s agenda also includes earnings calls from major hea…
    STAT · 13d agoNeutral↗ source
  • Roche's KRAS inhibitor divarasib shows strong results in second-line lung cancer trial at ESMO
    Roche presented data from a trial of its KRAS G12C inhibitor divarasib at the European Society for Medical Oncology meeting. The study evaluated divarasib in patients with advanced non-small cell…
    STAT · 14d agoPositive readoutPositive↗ source