The U.S. Food and Drug Administration on Sept. 21 approved Incyte Corp.’s cream Opzelura for treating the inflammatory skin condition atopic dermatitis, commonly called eczema, in adolescents and adults with boxed warnings.
The U.S. Food and Drug Administration approved Jazz Pharmaceuticals’ Xywav for idiopathic hypersomnia in adults.
The U.S. Food and Drug Administration granted accelerated approval of Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.
Intra-Cellular Therapies Inc.’s lead drug to treat schizophrenia in adults received approval from the U.S. Food and Drug Administration, sending the company’s shares soaring 85 percent.
The U.S. FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting.
The U.S. Food and Drug Administration approved Amgen Inc.’s biosimilar copy of Johnson & Johnson’s blockbuster rheumatoid arthritis (RA) drug Remicade.
Noven Pharmaceuticals won approval from the U.S. Food and Drug Administration for the company’s transdermal schizophrenia patch.
The U.S. FDA approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism in pediatric patients 1 month of age and older.
Amgen and UCB announced that the U.S. FDA approved Evenity (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
EMD Serono, a unit of Merck KGaA, announced that the U.S. FDA approved Mavenclad (cladribine) for adults with relapsing-remitting multiple sclerosis and active secondary progressive disease.