Source facts
FDA issued an approval letter for COLUMVI on 2026-05-29. The source metadata identifies BLA 761309 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
COLUMVI — FDA Approval Letter (BLA 761309)
Issued to GENENTECH INC. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for COLUMVI?
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 761309.
- 3Submission: supplement.
- 4Sponsor: GENENTECH INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the COLUMVI approval letter
Is COLUMVI FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761309 for COLUMVI, sponsored by GENENTECH INC, 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 761309?
BLA 761309 is the application under which FDA issued this approval letter for COLUMVI to GENENTECH INC. 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.