Pharmaceuticals, Biotechnology and Life Sciences
The U.S. Food and Drug Administration (FDA) expanded the approved indication for Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for the treatment of cystic fibrosis (CF).
U.S. Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for use in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Pfizer’s Xeljanz (tofacitinib citrate) 5 mg twice daily (BID) and XeljanzXR extended release 11 mg once daily use the treatment of adult patients with active psoriatic arthritis (PsA).
The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.
Diplomat Pharmacy will distribute Zejula (niraparib) for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
U.S. Food and Drug Administration (FDA) has set a PDUFA date of September 8, 2017 for its decision on the New Drug Application (NDA) for Nicox’s Zerviate (cetirizine ophthalmic solution) 0.24%.
U.S. Food and Drug Administration (FDA) has approved supplemental indications for Gilead Sciences’s Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg.
The U.S. FDA will review a supplemental New Drug Application for Janssen’s Imbruvica for chronic graft-versus-host-disease after failed certain therapies.
U.S. Food and Drug Administration (FDA) has approved Teva’s Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease (HD).
Kitov Pharmaceuticals Holdings Ltd, a NASDAQ and TASE listed innovative biopharmaceutical company, said Monday that that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application filing fee for Kitov’s patented combination of …