The approval was based on data from the randomized, placebo-controlled, double-blind, phase 3 RATIONALE-305 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.

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.

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 ...

(HealthDay News) — A high omega-3, low omega-6 diet with fish oil supplementation for one year results in a significant reduction of a marker of prostate cancer progression among men enrolled in ...

(HealthDay News) — Higher daily step counts are associated with fewer depressive symptoms in adults, according to a systematic review and meta-analysis published online online December 16 in JAMA ...

Fewer thromboembolic events were seen in association with higher- vs lower-dose anticoagulation, but the risk for major bleeding was greater. (HealthDay News) — For patients hospitalized for COVID-19, ...

Results from the VENTURE trial showed significant reductions in weight and hunger among younger patients treated with ...

ACIP recommends extending interval for two-dose series and adding three-dose series in accordance with FDA label ...

The BLA acceptance was supported by data from the randomized, placebo-controlled phase 2b/3 CLEVER trial as well as interim ...

The Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one ...