Sanofi's Tzield (teplizumab-mzwv) received FDA approval today for an expanded indication to delay stage 3 type 1 diabetes onset in children as young as one year with stage 2 disease, driving trader consensus to 100% "Yes" on Polymarket. This supplemental biologics license application followed priority review acceptance in January 2026—ahead of the April 29 PDUFA target—building on the drug's 2022 approval for patients aged 8+. Strong clinical data from prior trials and expedited review via a National Priority Voucher fueled optimism, with Sanofi's official announcement confirming the decision. While post-approval label changes or rare manufacturing issues could theoretically prompt revisits, such scenarios are negligible given the binding regulatory greenlight and market-implied certainty.