The approval was based on data from the randomized, placebo-controlled, double-blind, phase 3 RATIONALE-305 trial.
According to Vertex Pharmaceuticals, approximately 300 additional people with CF are now eligible to receive treatment.
(HealthDay News) — For adults with migraine, atogepant 60mg once daily was superior to placebo for efficacy and functional measures of treatment across 3 trials, according to research published online ...
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 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.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 URO-901-3005 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 ...
In both cross-sectional and panel studies, there was an inverse association for daily steps with depressive symptoms. (HealthDay News) — Higher daily step counts are associated with fewer ...
Ki-67 index decreased in the D + FO group by approximately 15% from baseline to 1 year (1.34 to 1.14% at one year). (HealthDay News) — A high omega-3, low omega-6 diet with fish oil ...