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9 stories matching this filter · ← front page

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  • FDA authorizes Aletta, first standalone robotic device for automated blood draws
    The U.S. Food and Drug Administration announced it has authorized Aletta, a robotic system that can draw blood without hands‑on operator involvement. The device is cleared for adult use in outpati…
    fda press · 18h agoRegulatoryPositive↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 13d agoApprovalPositive↗ source
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Ophthalmology419
Endocrinology & Metabolism377
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Infectious Disease346
  • FDA releases new guidances on adhesive performance and skin irritation studies for transdermal generic drugs
    The U.S. Food and Drug Administration has issued two new guidances that address transdermal or topical delivery systems for generic drugs. One is a final guidance that outlines how to assess adhesi…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA releases new guidances on adhesives and skin irritation testing for transdermal drug products
    The U.S. Food and Drug Administration has issued two new guidances that focus on transdermal and topical delivery systems used for generic medicines. One guidance, finalized, provides recommendati…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
    The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an in…
    fda press · 2mo ago↗ source
  • FDA Expands Sunscreen Options for the First Time in 20 Years
    Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen i…
    fda press · 2mo ago↗ source
  • Dr Postow on an Ideal Post-ICI Monitoring Framework in Melanoma
    Michael A. Postow, MD, discusses the importance of long-term multidisciplinary follow-up for patients with melanoma treated with ICIs.
    onclive · 3mo ago↗ source
  • Five Under 5: Top Oncology Videos for the Week of 5/3
    The top 5 OncLive TV videos of the week cover insights in ovarian cancer, classical Hodgkin lymphoma, pancreatic cancer, melanoma, and myelofibrosis.
    onclive · 3mo ago↗ source