APPLICATION
BLA761400
TYPE
BLA
ORIGINAL APPROVAL
2025-07-02
LATEST ACTION
2025-07-02
ROUTE
INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LYNOZYFICPrescription
LINVOSELTAMAB-GCPT 5MG/2ML · SOLUTION · INJECTION
Approval history
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.