APPLICATION
BLA761434
TYPE
BLA
ORIGINAL APPROVAL
2025-11-25
LATEST ACTION
2025-11-25
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VOYXACTPrescription
SIBEPRENLIMAB-SZSI 400MG/2ML(200MG/ML) · INJECTABLE · 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.