← FDA DRUG APPROVALS

FDA BLA · BLA761324

EPKINLY

epcoritamab-bysp

Sponsor: GENMAB US, INC.

APPLICATION
BLA761324
TYPE
BLA
ORIGINAL APPROVAL
2023-05-19
LATEST ACTION
2026-06-17
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

EPKINLYPrescription
EPCORITAMAB-BYSP 4MG/0.8ML · INJECTABLE · SUBCUTANEOUS
EPKINLYPrescription
EPCORITAMAB-BYSP 48MG/0.8ML · INJECTABLE · SUBCUTANEOUS

Approval history

2026-06-17Labeling · Supplement 11 · standard — Letter ↗AP
2026-03-27Efficacy · Supplement 10 · standard — Label ↗AP
2025-11-18Efficacy · Supplement 9 · priority — Letter ↗AP
2025-09-11Labeling · Supplement 8 · standard — Letter ↗AP
2024-06-26Efficacy · Supplement 3 · priority — Label ↗AP
2023-05-19Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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