← FDA DRUG APPROVALS

FDA BLA · BLA761049

BAVENCIO

avelumab

Sponsor: EMD SERONO INC

APPLICATION
BLA761049
TYPE
BLA
ORIGINAL APPROVAL
2017-03-23
LATEST ACTION
2025-06-04
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BAVENCIOPrescription
AVELUMAB 20MG/ML · INJECTABLE · INJECTION

Approval history

2025-06-04Labeling · Supplement 21 · standard — Label ↗AP
2024-11-26Labeling · Supplement 20 · standard — Letter ↗AP
2024-10-11Efficacy · Supplement 19 · standard — Label ↗AP
2024-03-06Labeling · Supplement 16 · standard — Label ↗AP
2023-09-06Efficacy · Supplement 15 · standard — Letter ↗AP
2022-07-15Efficacy · Supplement 13 · standard — Letter ↗AP
2020-11-10Labeling · Supplement 5 · standard — Letter ↗AP
2020-06-30Efficacy · Supplement 9 · priority — Label ↗AP
2019-05-14Efficacy · Supplement 6 · priority — Label ↗AP
2018-10-19Efficacy · Supplement 3 · standard — Letter ↗AP
2017-10-12Labeling · Supplement 2 · standard — Label ↗AP
2017-04-25Labeling · Supplement 1 · standard — Letter ↗AP
2017-03-23Type 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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