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May 6, 2024

FDA accepts BLA for BMS’ subcutaneous nivolumab to treat solid tumours

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) biologics license application (BLA) for the subcutaneous formulation of Opdivo (nivolumab) formulated along with Halozyme’s recombinant human hyaluronidase (rHuPH20) [referred as subcutaneous nivolumab] for previously approved solid tumour indications for the drug.

A regulatory decision on the approval for BMS’ subcutaneous nivolumab under the Prescription Drug User Fee Act (PDUFA) is expected on 28 February next year. Credit: Bristol-Myers Squibb Company.