Makary era reversals continue with another ultra-rare U-turn by FDA

FDA has put another therapy for an ultra-rare condition back on a path toward approval, reversing a rejection issued under former Commissioner Marty Makary.

Saol Therapeutics LLC announced Tuesday that FDA is permitting it to resubmit the NDA for SL1009, sodium dichloroacetate (DCA), as a treatment for pyruvate dehydrogenase complex deficiency (PDCD). ...