Posted by Michael Wonder on 21 May 2024
Bristol Myers Squibb announces updated action date by the US FDA for subcutaneous nivolumab (nivolumab and hyaluronidase)
21 May 2024 - Updated PDUFA goal date of 29 December 2024.
Bristol Myers Squibb today announced that the US FDA has reassigned the previously announced PDUFA goal date of the Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase across all previously approved adult, solid tumour Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
