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  • Paxlovid Moves Closer to Full FDA Approval

    14 days ago - By Time

    WASHINGTON - Pfizer's COVID-19 pill Paxlovid won another vote of confidence from U.S. health advisers Thursday, clearing the way for its full regulatory approval by the Food and Drug Administration.
    The medication has been used by millions of Americans since the FDA granted it emergency use authorization in late 2021. The agency has the final say on giving Pfizer's drug full approval and is expected to decide by May.
    A panel of outside experts voted 16-1 that Paxlovid remains a safe and effective treatment for high-risk adults with COVID-19 who are more likely to face hospitalization and...
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  • STAT+: FDA to convene advisory panel for Sarepta's gene therapy for Duchenne

    14 days ago - By STAT

    In a sudden about-face, the Food and Drug Administration will hold a meeting of outside experts to consider whether or not to approve Sarepta's experimental gene therapy for Duchenne muscular dystrophy.
    The announcement Thursday comes just weeks after the company said the FDA had told it an advisory panel meeting to review the treatment, called SRP-9001, would not be necessary. The decision to review Sarepta's gene therapy without input from outside experts surprised some analysts and patient advocates. Continue to STAT+ to read the full story...
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  • FDA Commissioner: Insurers Need To Support Studies In Accelerated Drug Approval Pathway

    FDA Commissioner: Insurers Need To Support Studies In Accelerated Drug Approval Pathway

    14 days ago - By MedCity News

    Physicians face a lot of barriers from insurers in completing studies on drugs in the accelerated approval pathway, declared Dr. Robert Califf, commissioner of food and drugs at the Food and Drug Administration. Insurers need to help, he said during the AHIP Medicare, Medicaid, Duals and Commercial Markets Forum.
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