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FDA grants priority review designation to Gilead Sciences’s HIV drug

The U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for Gilead Sciences’s investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection.

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FDA OK’s Gilead Sciences’s hepatitis C drug

The U.S. Food and Drug Administration (FDA) has approved updated labeling for Gilead Sciences’s Epclusa (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV.

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FDA OK’s Gilead Sciences’s hepatitis C drug for pediatric patients

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.

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