← FDA DRUG APPROVALS

FDA BLA · BLA761238

BRIUMVI

ublituximab

Sponsor: TG THERAPEUTICS, INC

APPLICATION
BLA761238
TYPE
BLA
ORIGINAL APPROVAL
2022-12-28
LATEST ACTION
2026-01-16
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BRIUMVIPrescription
UBLITUXIMAB-XIIY 25 MG/ML · INJECTABLE · INTRAVENOUS

Approval history

2026-01-16Labeling · Supplement 26 · standard — Label ↗AP
2025-08-18Labeling · Supplement 22 · standard — Letter ↗AP
2025-08-18Labeling · Supplement 25 · standard — Letter ↗AP
2024-10-30Labeling · Supplement 11 · standard — Label ↗AP
2022-12-28Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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