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# FDA Accepts BMS sBLA for Opdivo
- URL: https://www.fdaweb.com/fda-accepts-bms-sbla-for-opdivo/
- Published: 2017-07-24T12:00:00.000Z
- Updated: 2026-09-14T22:35:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139207

FDA has accepted a Bristol-Myers Squibb supplemental BLA to update Opdivo (nivolumab) dosing to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications. The agency has set a user fee review action (XXX DELETE XX)date of 3/5/2018\. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to “harness” the body’s own immune system to help restore anti-tumor immune response,” according to the company.