← FDA DRUG APPROVALS

FDA BLA · BLA761234

OPDUALAG

nivolumab and relatlimab-rmbw

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
BLA761234
TYPE
BLA
ORIGINAL APPROVAL
2022-03-18
LATEST ACTION
2026-06-08
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

OPDUALAGPrescription
NIVOLUMAB 240MG, RELATLIMAB-RMBW 80MG · SOLUTION · INTRAVENOUS

Approval history

2026-06-08Labeling · Supplement 11 · standard — Letter ↗AP
2024-03-06Labeling · Supplement 6 · standard — Label ↗AP
2022-03-18Type 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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