HEMLIBRA (EMICIZUMAB)
Summary
FDA approved HEMLIBRA (EMICIZUMAB) by GENENTECH INC. BLA (Biologic) approval (Labeling) on 2025-07-08. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
BLA761083-20
Action Date
2025-07-08
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
HEMLIBRA (generic: EMICIZUMAB), INJECTABLE, INJECTION. Application: BLA761083
Company
Context & Analysis
GENENTECH INC has 11 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
How often does GENENTECH INC have FDA actions?
GENENTECH INC has 11 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "BLA761083-20" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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