Tzield (teplizumab) PDUFA Date (Sanofi)

Name: FDA PDUFA Decision: Tzield (teplizumab)
Start: 2026-04-29

FDA PDUFA decision date for Tzield (teplizumab) is April 29, 2026. Developed by Sanofi. Indication: Type 1 diabetes (age expansion). Current status: Approved.

Indication

Type 1 diabetes (age expansion)

Regulatory details

Company: Sanofi
Therapeutic area: Immunology / Endocrine
Application type: sBLA
Review type: Priority
PDUFA date: 2026-04-29
Outcome: Approved

Tzield (teplizumab) PDUFA Date — Sanofi