Treats relapsing forms of multiple sclerosis (MS). BLA 761238, held by Tg Therapeutics, Inc. Ublituximab-Xiiy.
As of Nov 13, 2026, BLA 761238 (Briumvi), held by Tg Therapeutics, Inc, was first approved by FDA on Dec 28, 2022, with 4 approved supplements and 0 published complete response letters.
BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 28, 2022 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Briumvi25 MG/ML · injectable;intravenous | Ublituximab-Xiiy | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 16, 2026 | Supplement 26Labeling · Standard review | Approved | |
| Aug 18, 2025 | Supplement 22Labeling · Standard review | Approved | |
| Aug 18, 2025 | Supplement 25Labeling · Standard review | Approved | |
| Oct 30, 2024 | Supplement 11Labeling · Standard review | Approved | |
| Dec 28, 2022 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
