June 15, 2026
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The FDA has granted accelerated approval for teplizumab-mzwv as the first disease-modifying therapy for children and adolescents with stage 3 type 1 diabetes, according to an industry press release. As Healio previously reported, teplizumab-mzwv (Tzield, Sanofi) was originally approved by the FDA in November 2022 to delay stage 3 type 1 diabetes among children and adults with stage 2 disease. In
Sanofi's Tzield received FDA approval for pediatric type 1 diabetes stage 3, reducing C-peptide decline to 0.13 pmol/mL vs placebo in a 328-patient trial. The therapy advances autoimmune diabetes treatment, expanding disease-modifying options for children and adolescents.
June 15, 2026
1 min read
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