approval · primary record
NIVOLUMAB
4 approval events · latest 2026-08-12
| Agency | FDA |
|---|---|
| Submission type | BLA |
| Latest action | 2026-08-12 |
| Approval events | 4 |
| Brand | OPDIVO |
| Sponsor | BRISTOL MYERS SQUIBB |
| Route | INJECTION |
Approval history
4 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-08-12 | FDA | BLA | OPDIVO | BRISTOL MYERS SQUIBB | INJECTION |
| 2026-06-08 | FDA | BLA | OPDUALAG | BRISTOL MYERS SQUIBB | INTRAVENOUS |
| 2026-05-12 | FDA | BLA | OPDIVO QVANTIG | BRISTOL-MYERS SQUIBB | SUBCUTANEOUS |
| 2024-12-27 | FDA | BLA | OPDIVO QVANTIG | BRISTOL-MYERS SQUIBB | INJECTION |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:30:22.594Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:nivolumab
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.