The FDA has approved Semglee™ (insulin glargine injection; Mylan and Biocon) to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Isturisa is exclusively available through the R.A.R.E.™ Patient Support Program and distributed via AnovoRx specialty pharmacy.
Testing revealed that the product may have up to 115% of the labeled amount of Liothyronine (T3) (acceptable range is 90.0-110.0%).
Amarin Corporation announced results from the phase 3 REDUCE-IT study of icosapent ethyl (Vascepa) demonstrating a significant reduction in coronary revascularization procedures in high risk patients with mixed dyslipidemia.
The FDA Phexxi™ (lactic acid, citric acid and potassium bitartrate; Evofem Biosciences) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for setmelanotide for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.
The FDA has approved Farxiga (dapagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction with and without type 2 diabetes.
The FDA has granted Orphan Drug designation to ABG-023, a glucagon analog (AmideBio), for the treatment of congenital hyperinsulinism.
A phase 3 trial to evaluate dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, as a potential treatment for patients hospitalized with coronavirus disease 2019.