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 ...

The Orphan Drug designation is based on data from the dose escalation phase of the open-label phase 1/2 study.

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

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

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 ...

Concizumab is a tissue factor pathway inhibitor antagonist that enhances factor Xa production during the initiation phase of coagulation. This production improves thrombin generation and clot ...

(HealthDay News) — Light-to-moderate consumption of wine, measured through an objective urinary biomarker, is associated with lower cardiovascular disease (CVD) risk in an older Mediterranean ...