KADCYLA (ADO-TRASTUZUMAB EMTANSINE)
Summary
FDA approved KADCYLA (ADO-TRASTUZUMAB EMTANSINE) by GENENTECH. BLA (Biologic) approval (Labeling) on 2026-03-26. VIAL, SINGLE-USE.
Details
Source
Drug Approval
External ID
BLA125427-125
Action Date
2026-03-26
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
KADCYLA (generic: ADO-TRASTUZUMAB EMTANSINE), VIAL, SINGLE-USE. Application: BLA125427
Company
Context & Analysis
GENENTECH has 6 FDA actions in our database.
Frequently Asked Questions
How often does GENENTECH have FDA actions?
GENENTECH has 6 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 "BLA125427-125" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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