Dapagliflozin was recently approved for T1D in Europe and Japan.
The FDA has granted Fast Track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization in patients with chronic heart failure.
The approval of Victoza in this patient population was based on data from the ELLIPSE trial which included 134 children and adolescents.
Slynd contains drospirenone, a spironolactone analogue.
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Vascepa (icosapent ethyl; Amarin) to reduce residual cardiovascular.
The Food and Drug Administration (FDA) has approved updated labeling for Farxiga (dapagliflozin; AstraZeneca) and Xigduo XR (dapagliflozin and metformin HCl extended-release; AstraZeneca) to expand the use of these products in type 2 diabetes patients with moderate renal impairment.
Topline data from the Phase 3 STELLAR-4 trial showed that selonsertib, an investigational treatment for patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH), was not associated with a significant improvement in fibrosis without worsening of NASH.