Halozyme Announces Bristol Myers Squibb Received Updated Action Date from the U.S. Food and Drug Administration for Subcutaneous Nivolumab Co-Formulated with ENHANZE®
HALOHalozyme(HALO) prnewswire.com·2024-05-21 19:15

Updated Prescription Drug User Fee Act goal date of December 29, 2024SAN DIEGO, May 21, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Bristol Myers Squibb was reassigned a Prescription Drug User Fee Act goal date from the U.S. Food and Drug Administration for their Biologics License Application for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, across ...