BENLYSTA (BELIMUMAB)
Summary
FDA approved BENLYSTA (BELIMUMAB) by HUMAN GENOME SCIENCES INC.. BLA (Biologic) approval (Labeling) on 2025-06-20. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
BLA125370-85
Action Date
2025-06-20
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
BENLYSTA (generic: BELIMUMAB), INJECTABLE, INJECTION. Application: BLA125370
Company
Context & Analysis
Frequently Asked Questions
How often does HUMAN GENOME SCIENCES INC. have FDA actions?
This is the only FDA action we have on record for HUMAN GENOME SCIENCES INC. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "BLA125370-85" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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