At a recent meeting of the AAMI Healthcare Technology Safety Institute, researchers from the University of Toronto released a report that provides nine specific recommendations to reduce the risks ...
A Prescription Drug User Fee Act target date of February 1, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) ...
The FDA has accepted for review the supplemental Biologics License Application (sBLA) for a 2-hour Ocrevus (ocrelizumab; Genentech) infusion time, shortening the conventional infusion duration for ...
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