← FDA DRUG APPROVALS

FDA BLA · BLA761097

LIBTAYO

cemiplimab-rwlc

Sponsor: REGENERON PHARMACEUTICALS

APPLICATION
BLA761097
TYPE
BLA
ORIGINAL APPROVAL
2018-09-28
LATEST ACTION
2025-10-29
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LIBTAYOPrescription
CEMIPLIMAB-RWLC 350MG · INJECTABLE · INTRAVENOUS

Approval history

2025-10-29Efficacy · Supplement 32 · priority — Letter ↗AP
2025-10-08Efficacy · Supplement 30 · priority — Label ↗AP
2024-04-05Efficacy · Supplement 23 · standard — Letter ↗AP
2024-03-06Labeling · Supplement 25 · standard — Letter ↗AP
2023-04-28Efficacy · Supplement 16 · standard — Letter ↗AP
2023-04-28Efficacy · Supplement 15 · standard — Letter ↗AP
2022-11-08Efficacy · Supplement 14 · standard — Label ↗AP
2021-02-22Efficacy · Supplement 7 · priority — Label ↗AP
2021-02-09Efficacy · Supplement 8 · priority — Label ↗AP
2021-02-09Efficacy · Supplement 9 · priority — Label ↗AP
2020-11-10Labeling · Supplement 3 · standard — Letter ↗AP
2020-06-25Efficacy · Supplement 5 · standard — Label ↗AP
2019-03-20Labeling · Supplement 1 · standard — Label ↗AP
2019-01-18Labeling · Supplement 2 · standard — Label ↗AP
2018-09-28Type 1 - New Molecular Entity · Original · priority — Letter ↗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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