The ongoing shortage of liraglutide injection and other GLP-1 medications prompted the FDA to prioritize the generic drug applications for these medications in order to improve patient access.

The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 URO-901-3005 trial.

The resubmitted NDA for sotagliflozin for adults with T1D and CKD included post hoc analyses from the TANDEM clinical development program and post hoc analysis from the SCORED trial.

At week 16, both trials showed a significantly greater proportion of deucravacitinib-treated patients achieved ACR20 response compared with placebo. Topline data were announced from two phase 3 trials ...