BLA 761234, held by Bristol Myers Squibb. Nivolumab;Relatlimab-Rmbw.
As of Nov 13, 2026, BLA 761234 (Opdualag), held by Bristol Myers Squibb, was first approved by FDA on Mar 18, 2022, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2022 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Opdualag240MG;80MG · solution;intravenous | Nivolumab;Relatlimab-Rmbw | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 8, 2026 | Supplement 11Labeling · Standard review | Approved | |
| Mar 6, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Mar 18, 2022 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
