The Food and Drug Administration (FDA) has approved label changes for Olysio (simeprevir; Janssen) to include dosing recommendations for the treatment of hepatitis C virus (HCV)/HIV-1 co-infection, and to expand the indications and usage to include genotype 4 infection.
The Food and Drug Administration (FDA) has granted Fast Track designation to TXA127 (angiotensin 1-7; Tarix Orphan) to reduce skeletal muscle damage and fibrosis and thereby improve muscle strength in Duchenne Muscular Dystrophy (DMD) patients.
The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to three supplemental New Drug Applications (sNDAs) for Daklinza (daclatasvir; BMS) for use with sofosbuvir with or without ribavirin for the treatment of patients with chronic hepatitis C (HCV) co-infected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV.
Alkermes announced that the Food and Drug Administration (FDA) has approved Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.
The Food and Drug Administration (FDA) has ordered the three manufacturers of duodenoscopes marketed in the United States to conduct postmarket surveillance studies for greater understanding of how the devices are reprocessed in real-world settings.