← FDA DRUG APPROVALS

FDA BLA · BLA761232

TEVIMBRA

tislelizumab-jsgr

Sponsor: BEIGENE

APPLICATION
BLA761232
TYPE
BLA
ORIGINAL APPROVAL
2024-03-13
LATEST ACTION
2025-12-09
ROUTE
INTRAVENOUS, SOLUTION
DOSAGE FORM
INJECTION
MARKETING STATUS
Prescription

Products

TEVIMBRAPrescription
TISLELIZUMAB-JSGR 100MG/10ML · INJECTION · SOLUTION

Approval history

2025-12-09Efficacy · Supplement 10 · standard — Letter ↗AP
2025-12-09Efficacy · Supplement 9 · standard — Letter ↗AP
2025-12-09Efficacy · Supplement 13 · standard — Letter ↗AP
2025-12-02Labeling · Supplement 15 · standardAP
2025-05-01Labeling · Supplement 4 · standard — Letter ↗AP
2025-04-22Efficacy · Supplement 2 · standard — Label ↗AP
2025-04-22Efficacy · Supplement 12 · standard — Label ↗AP
2025-04-22Efficacy · Supplement 5 · standard — Label ↗AP
2025-04-22Efficacy · Supplement 3 · standard — Label ↗AP
2025-04-22Efficacy · Supplement 11 · standard — Label ↗AP
2025-04-22Efficacy · Supplement 6 · standard — Label ↗AP
2024-03-13Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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