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8 stories matching this filter · ← front page

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STAT1542Endpoints1211BioSpace550Fierce Biotech545BioPharma Dive461raps189onclive165fda recalls
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allOncology10298Rare Disease2684Immunology2407Cardiology2275Hematology1865Pulmonology1837Vaccines1609
  • Former FDA chief Califf calls for regulatory overhaul and predicts AI assistants in future oversight
    Robert Califf, who served as FDA commissioner, reflected on his early experience as a medical student in the 1970s working with a pioneering patient database that tracked cardiovascular procedures…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA approves AstraZeneca breast cancer drug despite negative advisory committee vote; Novartis faces cholesterol drug setbacks
    The U.S. Food and Drug Administration granted approval to AstraZeneca's breast cancer therapy even though the advisory committee voted against it. The decision underscores the agency's willingness…
    raps · 1mo agoRegulatoryNeutral↗ source
102
fda medwatch89
globenewswire health73
fda press51
Psychiatry & CNS1100
Ophthalmology840
Endocrinology & Metabolism682
Pain650
Nephrology627
  • FDA releases FY 2027 user fee rates for prescription, generic, biosimilar, device and over the counter programs
    The U.S. Food and Drug Administration has published its user fee schedule for fiscal year 2027. The rates cover prescription drugs, generic drugs, biosimilars, medical devices and over the counter…
    raps · 2mo agoRegulatoryNeutral↗ source
  • REVELUTION-2 trial assesses cardiovascular safety of relugolix plus abiraterone in high‑risk prostate cancer
    The REVELUTION-2 study is focused on measuring the heart‑related risks associated with a hormone‑therapy regimen that combines relugolix and abiraterone acetate in patients with high‑risk prostate…
    onclive · 5mo agoNeutral↗ source
  • Experts highlight need for broader monitoring in polycythemia vera as patient shows disease progression despite controlled hematocrit
    A 68-year‑old woman with a six‑year history of polycythemia vera (PV) and prior deep‑vein thrombosis has kept her hematocrit below 45% on hydroxyurea, indicating good control of that metric. Desp…
    onclive · 5mo agoNeutral↗ source
  • Utah invests in AI supercomputer to boost health research and biotech innovation
    State of Utah announced a major investment in artificial intelligence and high-performance computing infrastructure aimed at accelerating health research. The new AI supercomputer, managed by the…
    onclive · 5mo agoPositive↗ source
  • Experts discuss mutation testing and patient factors to guide second-line CLL therapy after BTK inhibitor resistance
    A 66-year-old man who was diagnosed with chronic lymphocytic leukemia five years ago and initially had an unmutated IGHV profile without TP53 alteration has been on continuous covalent BTK inhibito…
    onclive · 5mo agoNeutral↗ source
  • Study links specific dietary fats to pancreatic cancer risk, highlighting oleic acid as promoter and omega-3s as protective
    Researchers at Yale Cancer Center examined how different types of dietary fat affect pancreatic cancer development in a mouse model. Rather than focusing on total fat intake, the study compared twe…
    onclive · 5mo agoNeutral↗ source