Tag: Gilead Sciences

FDA grants priority review designation to Gilead Sciences’s HIV drug
August 11, 2017 Off

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

By Dino Mustafić

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.

FDA OK’s Gilead Sciences’s hepatitis C drug
August 2, 2017 Off

FDA OK’s Gilead Sciences’s hepatitis C drug

By Dino Mustafić

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.

FDA OK’s Gilead Sciences’s hepatitis C drug for pediatric patients
April 7, 2017 Off

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

By Dino Mustafić

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.

Gilead to present preclinical HIV study at CROI 2017
February 14, 2017 Off

Gilead to present preclinical HIV study at CROI 2017

By Dino Mustafić

Gilead Sciences will present findings from a preclinical study evaluating HIV capsid inhibitors (CAIs) for potential use as a long-acting antiretroviral (ARV) treatment, at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.