Sanofi’s Tzield (teplizumab) gained FDA accelerated clearance for recently diagnosed stage 3 type 1 diabetes, expanding the CD3-directed monoclonal antibody’s disease-modifying use. The decision followed back-and-forth on whether the therapy should be included in the Commissioner’s National Priority Voucher program, which is controversial within industry due to its policy mechanics. The FDA’s accelerated approval was supported by a surrogate endpoint measuring C-peptide decline, enabling broader access for stage 3 T1D patients and setting up competition around C-peptide as a future regulatory pathway.