Source facts
FDA issued an approval letter for OPDIVO on 2026-03-23. The source metadata identifies BLA 125554 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
OPDIVO — FDA Approval Letter (BLA 125554)
Issued to BRISTOL MYERS SQUIBB. Application is approved as submitted.
Issued
March 23, 2026Application
BLA • 125554
Product
OPDIVO
Company
BRISTOL MYERS SQUIBB
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for OPDIVO?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: BLA 125554.
- 3Submission: supplement.
- 4Sponsor: BRISTOL MYERS SQUIBB.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the OPDIVO approval letter
Is OPDIVO FDA approved?
This letter documents an FDA approval action: FDA approved BLA 125554 for OPDIVO, sponsored by BRISTOL MYERS SQUIBB, on March 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 125554?
BLA 125554 is the application under which FDA issued this approval letter for OPDIVO to BRISTOL MYERS SQUIBB. The letter is dated March 23, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.