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 ...

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, ...

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.

(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 ...

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 ...

Veligrotug is an investigational monoclonal antibody that inhibits the activity of insulin-like growth factor-1 receptor.

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