FDA Accepts BMS’s BLA for Subcutaneous Nivolumab
The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the subcutaneous formulation of nivolumab (Opdivo, BMS) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) or subcutaneous nivolumab across all previously approved adult solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab (Yervoy, Bristol Myers Squibb) combination […]