APPLICATION
BLA761310
TYPE
BLA
ORIGINAL APPROVAL
2022-11-14
LATEST ACTION
2025-07-14
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ELAHEREPrescription
MIRVETUXIMAB SORAVTANSINE-GYNX 100mg/20mL single-dose vial · INJECTABLE · INJECTION
Approval history
2025-07-14Labeling · Supplement 10 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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