Reported delays to FDA reviews under new fast-track program

As many as four decisions under the US Food and Drug Administration’s (FDA) new fast-track program have been delayed, Reuters has reported.

The report states that FDA reviewers have pushed back by two weeks their announcement of a verdict on Disc Medicine's (Nasdaq: IRON) bitopertin, an experimental drug for a rare blood disorder, following concerns about trial data and its risk for abuse.

Their review of French drugmaker Sanofi's (Euronext: SAN) Tzield (teplizumab-mzwv) for late-stage type 1 diabetes has also been stalled by more than a month over adverse event reports, including two related to seizure and blood clotting and one death, the Reuters article adds.