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11 stories matching this filter · ← front page

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  • FDA approves first pediatric heart valve that expands as children grow
    The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…
    fda press · 18d agoApprovalPositive↗ source
  • FDA launches nationwide recruitment to broaden scientific and consumer representation on advisory committees
    The U.S. Food and Drug Administration announced a new nationwide effort to recruit qualified experts and consumer representatives for its advisory committees. The agency issued two Federal Register…
    fda press · 19d agoRegulatoryPositive↗ source
102
fda medwatch89
globenewswire health73
fda press51
Psychiatry & CNS1100
Ophthalmology840
Endocrinology & Metabolism682
Pain650
Nephrology627
  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 21d agoApprovalPositive↗ source
  • 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
  • FDA grants accelerated approval for Etcamah combo therapy for advanced HR-positive, HER2-negative breast cancer
    The U.S. Food and Drug Administration announced accelerated approval of Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone-receptor-positive, HER2-negativ…
    fda press · 1mo agoApprovalPositive↗ source
  • FDA approves Mimrylo, first hepcidin-mimicking drug for polycythemia vera
    The U.S. Food and Drug Administration announced approval of Mimrylo (rusfertide) for adult patients with polycythemia vera, a rare blood disorder that causes excess red blood cells. The drug mimic…
    fda press · 1mo agoApprovalPositive↗ source
  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 1mo agoApprovalPositive↗ source
  • 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
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 2mo agoRegulatoryPositive↗ source
  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 3mo agoApprovalPositive↗ source