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FDA BLA · BLA761334

ZYNYZ

retifanlimab-dlwr

Sponsor: INCYTE CORP

APPLICATION
BLA761334
TYPE
BLA
ORIGINAL APPROVAL
2023-03-22
LATEST ACTION
2026-05-18
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZYNYZPrescription
RETIFANLIMAB-DLWR 500MG/20ML(25MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2026-05-18Efficacy · Supplement 9 · standard — Label ↗AP
2026-03-30Efficacy · Supplement 8 · standard — Label ↗AP
2025-12-17Efficacy · Supplement 5 · standard — Letter ↗AP
2025-05-15Efficacy · Supplement 4 · priority — Label ↗AP
2024-04-22Labeling · Supplement 2 · standard — Label ↗AP
2023-03-22Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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