AVLAYAH (TIVIDENOFUSP ALFA-EKNM)
Summary
FDA approved AVLAYAH (TIVIDENOFUSP ALFA-EKNM) by DENALI THERAPEUTICS INC.. BLA (Biologic) approval (Type 1 - New Molecular Entity) on 2026-03-24. INJECTION, POWDER,FOR SOLUTION.
Details
Source
Drug Approval
External ID
BLA761485-1
Action Date
2026-03-24
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
AVLAYAH (generic: TIVIDENOFUSP ALFA-EKNM), INJECTION, POWDER,FOR SOLUTION. Application: BLA761485
Company
Context & Analysis
Frequently Asked Questions
How often does DENALI THERAPEUTICS INC. have FDA actions?
This is the only FDA action we have on record for DENALI THERAPEUTICS INC. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "BLA761485-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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