FDA Moves Up PDUFA Date for Subcutaneous Nivolumab
The U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of nivolumab (Opdivo, BMS) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) to Dec 29, 2024. The original PDUFA date was February 28, 2025. The BLA […]