KEYTRUDA (PEMBROLIZUMAB)
Summary
FDA approved KEYTRUDA (PEMBROLIZUMAB) by MERCK SHARP DOHME. BLA (Biologic) approval (Efficacy) on 2026-06-24. SOLUTION, INTRAVENOUS.
Details
Source
Drug Approval
External ID
BLA125514-187
Action Date
2026-06-24
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
KEYTRUDA (generic: PEMBROLIZUMAB), SOLUTION, INTRAVENOUS. Application: BLA125514
Company
Context & Analysis
MERCK SHARP DOHME has 5 FDA actions in our database.
Frequently Asked Questions
How often does MERCK SHARP DOHME have FDA actions?
MERCK SHARP DOHME 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 "BLA125514-187" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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