• STAT+: FDA threatens to fine another drug maker for failing to report clinical trial results

    1 month ago - By STAT

    For only the second time, the Food and Drug Administration is threatening to fine a drug maker for failing to submit required information about a clinical trial to a U.S. government registry.
    In a July 26 letter , the agency noted results of Phase 2 clinical test of a drug for treating acne rosacea had not been posted, even though the FDA contacted Accuitis last October about the issue. Acne rosacea is a condition that causes pus-filled bumps on the face and mostly affects middle-aged women with fair skin. Accuitis now has until Aug. 26 to post the data. Continue to STAT+ to read the full...
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  • STAT+: Congress presses the FDA to move faster on ALS drugs

    1 month ago - By STAT

    WASHINGTON - Lawmakers pressed a top Food and Drug Administration official Thursday for answers on why the agency has balked at approving medicines to treat the fatal neurodegenerative condition ALS. Two key politicians even called out specific drug candidates by name, a rare congressional boost for the biotechs behind them.
    The questions came during a hearing on neurodegenerative diseases hosted by the House Energy and Commerce committee that featured testimony from the National Institutes of Health, as well as patients and caregivers for conditions like Huntington's disease and...
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