Source facts
FDA issued an approval letter for BRIUMVI on 2026-01-22. The source metadata identifies BLA 761238 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
BRIUMVI — FDA Approval Letter (BLA 761238)
Issued to TG THERAPEUTICS, INC. Application is approved as submitted.
Issued
January 22, 2026Application
BLA • 761238
Product
BRIUMVI
Company
TG THERAPEUTICS, INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for BRIUMVI?
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 761238.
- 3Submission: supplement.
- 4Sponsor: TG THERAPEUTICS, INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the BRIUMVI approval letter
Is BRIUMVI FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761238 for BRIUMVI, sponsored by TG THERAPEUTICS, INC, on January 22, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761238?
BLA 761238 is the application under which FDA issued this approval letter for BRIUMVI to TG THERAPEUTICS, INC. The letter is dated January 22, 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.