Source facts
FDA issued an approval letter for IMFINZI on 2026-05-29. The source metadata identifies BLA 761069 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
IMFINZI — FDA Approval Letter (BLA 761069)
Issued to ASTRAZENECA UK LTD. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for IMFINZI?
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Key details in this letter
- 1FDA action: approval.
- 2Application: BLA 761069.
- 3Submission: supplement.
- 4Sponsor: ASTRAZENECA UK LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the IMFINZI approval letter
Is IMFINZI FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761069 for IMFINZI, sponsored by ASTRAZENECA UK LTD, on May 29, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761069?
BLA 761069 is the application under which FDA issued this approval letter for IMFINZI to ASTRAZENECA UK LTD. The letter is dated May 29, 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.