Bristol Myers Squibb (BMY) announced that the FDA will now decide on the biologics license application (BLA) for the subcutaneous formulation of Opdivo (nivolumab) on Dec 29, 2024. The subcutaneous formulation of Opdivo is co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20). The BLA seeks approval of the same across all previously approved adult, solid tumor indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or ...