
20 October 2025 - The US FDA has accepted for expedited review the supplemental biologics license application for Tzield (teplizumab-mzwv) to delay the progression of stage 3 type 1 diabetes in adults and paediatric patients eight years of age and older recently diagnosed with stage 3 type 1 diabetes.
The FDA nominated Tzield for the Commissioner's National Priority Voucher pilot program based on its potential to address a large unmet medical need.