← FDA DRUG APPROVALS

FDA BLA · BLA125377

YERVOY

ipilimumab

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
BLA125377
TYPE
BLA
ORIGINAL APPROVAL
2011-03-25
LATEST ACTION
2026-06-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

YERVOYPrescription
IPILIMUMAB 3MG · INJECTABLE · INJECTION

Approval history

2026-06-12Labeling · Supplement 138 · standard — Letter ↗AP
2025-05-23Efficacy · Supplement 136 · priority — Label ↗AP
2025-04-11Efficacy · Supplement 133 · standard — Letter ↗AP
2025-04-08Efficacy · Supplement 135 · priority — Letter ↗AP
2025-01-28Efficacy · Supplement 132 · standard — Label ↗AP
2023-02-15Efficacy · Supplement 129 · priority — Letter ↗AP
2022-11-23Labeling · Supplement 130 · standard — Letter ↗AP
2022-05-27Efficacy · Supplement 122 · standard — Letter ↗AP
2022-05-11Efficacy · Supplement 124 · standard — Letter ↗AP
2022-02-25Labeling · Supplement 126 · standard — Label ↗AP
2022-02-25Labeling · Supplement 127 · standard — Letter ↗AP
2021-05-25Efficacy · Supplement 121 · standard — Label ↗AP
2020-11-13Labeling · Supplement 119 · standard — Letter ↗AP
2020-10-02Efficacy · Supplement 115 · priority — Label ↗AP
2020-09-18Efficacy · Supplement 112 · standard — Letter ↗AP
2020-08-13Labeling · Supplement 111 · standard — Label ↗AP
2020-06-29Labeling · Supplement 106 · standard — Label ↗AP
2020-05-26Efficacy · Supplement 110 · priority — Label ↗AP
2020-05-15Efficacy · Supplement 109 · priority — Label ↗AP
2020-03-10Efficacy · Supplement 108 · priority — Letter ↗AP
2019-09-20Labeling · Supplement 104 · standard — Label ↗AP
2019-05-08Labeling · Supplement 102 · standard — Letter ↗AP
2018-07-10Efficacy · Supplement 96 · priority — Label ↗AP
2018-04-16Efficacy · Supplement 94 · priority — Label ↗AP
2018-02-08Labeling · Supplement 93 · standard — Label ↗AP
2017-12-13Labeling · Supplement 91 · standard — Label ↗AP
2017-10-20Efficacy · Supplement 86 · standard — Letter ↗AP
2017-07-21Efficacy · Supplement 87 · standard — Label ↗AP
2017-03-03Labeling · Supplement 84 · standard — Letter ↗AP
2015-10-28Efficacy · Supplement 73 · standard — Letter ↗AP
2015-08-17Labeling · Supplement 74 · standard — Label ↗AP
2015-03-19Labeling · Supplement 72 · standard — Letter ↗AP
2015-03-16REMS · Supplement 71AP
2013-12-05Labeling · Supplement 55 · standard — Label ↗AP
2013-05-22Labeling · Supplement 44 · standard — Label ↗AP
2012-10-26Labeling · Supplement 33 · standard — Label ↗AP
2012-02-16Labeling · Supplement 16 · standard — Letter ↗AP
2011-07-28Labeling · Supplement 8 · standardAP
2011-03-25Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
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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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