US FDA Accepts Sanofi's Application for Expanded Approval of Tzield for Priority Review

MT Newswires · 6d ago
01:31 AM EST, 01/05/2026 (MT Newswires) -- Sanofi (SAN.PA) said Monday the US Food and Drug Administration accepted its supplemental biologic license application for Tzield as a treatment for young children with stage 2 type 1 diabetes for priority review. The French pharmaceutical group is looking to expand the approved indication for the medication to at least one year old and above, from at least eight years old and above. The application is supported by positive interim one-year data from the ongoing phase 4 Petite-T1D study. The target action date for the regulatory decision is April 29.