FDA pushes back reviews of several fast-tracked medicines, Reuters reports

The Food and Drug Administration pushed back by two weeks a review of Disc Medicine’s (IRON) experimental drug for a rare blood disorder following concerns about trial data and its risk for abuse and stalled their review of Sanofi’s (SNY) Tzield for late-stage type 1 diabetes by more than a month over adverse event reports, delaying reviews of two drugs chosen for the Trump administration’s new fast-track program, internal documents seen by Reuters show. Two other drugs tapped for the speedy review program have also been pushed by weeks or longer beyond the original target date. A decision on Boehringer Ingelheim’s zongertinib for lung cancer is currently expected mid-February, and Eli Lilly’s (LLY) weight-loss pill is now due April 10, according to Reuters. Shares of Disc Medicine are down 7% to $71.95 in early trading following the report, while shares of Eli Lilly (LLY) are down 5% to $1,019.66.