FDA slows two fast-track drug reviews amid safety flags in voucher plan
Reuters reports the U.S. FDA has delayed reviews of two drugs selected for the National Priority Voucher fast-track program after agency scientists flagged safety and efficacy concerns, including a treatment-related death linked to one drug. Disc Medicine's experimental therapy for a rare blood disorder was pushed back due to questions about trial data and abuse risk, while Sanofi's Tzield for late-stage type 1 diabetes was delayed over adverse events, including seizures and a death. Two other program drugs—Boehringer Ingelheim's zongertinib and Lilly's weight-loss pill—were also delayed by weeks. The delays underscore the program’s aim to accelerate reviews only when warranted by robust safety/efficacy data, amid ongoing scrutiny of how political factors may influence drug decisions.