BLA 125527, held by Bristol Myers Squibb. Nivolumab.
As of Nov 13, 2026, BLA 125527 (Opdivo), held by Bristol Myers Squibb, was first approved by FDA on Mar 4, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 2015 | Original applicationNew indication · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
