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 ...

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 ...

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 ...

The FDA is recommending an additional clinical trial to confirm glepaglutide’s efficacy and safety at the to-be-marketed dose.

The single-use product is surgically implanted for arterial replacement and repair after a traumatic injury to the extremity.

CBD did not meet primary end point comparing preingestion to postingestion anxiety, but resulted in lower anxiety levels ...

The Food and Drug Administration (FDA) has approved Ryoncil ® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft vs host disease (SR-aGvHD) in pediatric patients 2 months of age ...

The Food and Drug Administration (FDA) has approved Tryngolza™ (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

The Food and Drug Administration (FDA) has approved Zepbound ® (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity.