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9 stories matching this filter · ← front page

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  • 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 · 1d agoRegulatoryNeutral↗ source
  • FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
    The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
    fda press · 8d ago↗ source
28
fda recalls22
fda press21
fda medwatch17
570
Vaccines507
Endocrinology & Metabolism289
Ophthalmology255
Infectious Disease252
Nephrology234
FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduc…
fda press · 14d ago↗ source
  • Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
    Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
    fda medwatch · 29d ago↗ source
  • REVELUTION-2 Trial Is Evaluating Cardiovascular Risk With Relugolix Plus Abiraterone Acetate in High-Risk Prostate Cancer
    Sagar A. Patel, MD, discusses the REVELUTION-2 trial evaluating cardiovascular safety with hormone therapy in prostate cancer.
    onclive · 2mo ago↗ source
  • Second Clinical Scenario - Progressive Disease Despite Hematocrit Control
    Polycythemia vera symptoms like fatigue and aquagenic itching signal active disease; experts urge objective tracking and tailored therapy beyond phlebotomy.
    onclive · 2mo ago↗ source
  • Transformational Utah Investment in Artificial Intelligence and Computing to Advance Health and Discovery
    The State of Utah has made a visionary investment in AI and advanced computing infrastructure to advance research.
    onclive · 2mo ago↗ source
  • Clinical Scenario Presentation and Treatment Approach for Progressive Disease
    Experts weigh mutation testing, comorbidities, and patient preference to guide second-line CLL options after BTK inhibitor resistance.
    onclive · 2mo ago↗ source
  • The Type of Fat—Not the Amount—Fuels Pancreatic Cancer
    Research from Yale Cancer Center showed that the type of fat consumed may matter more than amount in pancreatic cancer.
    onclive · 2mo ago↗ source