BLA 761417, held by Beigene. Tislelizumab-Jsgr.
As of Nov 13, 2026, BLA 761417 (Tevimbra), held by Beigene, was first approved by FDA on Dec 26, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 26, 2024 | Original applicationNew indication · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tevimbra100MG/10ML(10MG/ML) · injectable;intravenous | Tislelizumab-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
