DUPIXENT (DUPILUMAB)
Summary
FDA approved DUPIXENT (DUPILUMAB) by REGENERON PHARMACEUTICALS. BLA (Biologic) approval (Efficacy) on 2026-04-22. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
BLA761055-74
Action Date
2026-04-22
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
DUPIXENT (generic: DUPILUMAB), INJECTABLE, INJECTION. Application: BLA761055
Company
Context & Analysis
REGENERON PHARMACEUTICALS has 5 FDA actions in our database.
Frequently Asked Questions
How often does REGENERON PHARMACEUTICALS have FDA actions?
REGENERON PHARMACEUTICALS has 5 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "BLA761055-74" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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