Source facts
FDA issued an approval letter for TOFIDENCE on 2026-05-27. The source metadata identifies BLA 761354 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
TOFIDENCE — FDA Approval Letter (BLA 761354)
Issued to BIOGEN MA. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for TOFIDENCE?
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 761354.
- 3Submission: supplement.
- 4Sponsor: BIOGEN MA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the TOFIDENCE approval letter
Is TOFIDENCE FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761354 for TOFIDENCE, sponsored by BIOGEN MA, on May 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761354?
BLA 761354 is the application under which FDA issued this approval letter for TOFIDENCE to BIOGEN MA. The letter is dated May 27, 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.