Halozyme Announces Bristol Myers Squibb Received Updated Action Date from the U.S. Food and Drug Administration for Subcutaneous Nivolumab Co-Formulated with ENHANZE®
Updated Prescription Drug User Fee Act goal date of December 29, 2024
SAN 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 all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The updated goal date is December 29, 2024.