BLA 761380, held by Beigene. islelizumab-jsgr.
As of Nov 13, 2026, BLA 761380 (Tevimbra), held by Beigene, was first approved by FDA on Mar 3, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 3, 2025 | Original applicationNew indication · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tevimbra10 mg/mL · injectable;injection | islelizumab-jsgr | Rx |
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
