FDA grants accelerated approval to Sanofi Tzield for newly diagnosed stage 3 type 1 diabetes in children 8-17
PUBT · 6d ago
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- FDA granted accelerated approval to Sanofi’s Tzield to delay loss of endogenous insulin in children 8-17 recently diagnosed with stage 3 type 1 diabetes.
- Clearance relied on the PROTECT phase 3 study, which showed slower C-peptide decline versus placebo; continued approval hinges on confirmatory data.
- Sanofi has started the BETA-PRESERVE phase 3 confirmatory trial, now enrolling participants.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sanofi SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606121809OMX_____CNEWS_EN_GNW1001187483_en) on June 12, 2026, and is solely responsible for the information contained therein.
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