The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Epclusa (sofosbuvir + velpatasvir), from Gilead Sciences in chronic hepatitis C virus (HCV) infection.
Areas covered: Available data on epidemiology, type, and possible risk factors for nephrotoxicity of sofosbuvir-containing treatment are reviewed. Related articles were collected by searching Scopus, Pubmed, and Science direct.
The FDA has approved supplemental application for Harvoni (ledipasvir and sofosbuvir), from Gilead Sciences, to treat hepatitis C virus (HCV)...
The FDA has approved Harvoni (ledipasvir + sofosbuvir) for use in patients with hepatitis C virus (HCV) infection co-infected with...
Gilead Sciences announced that the European Commission has granted marketing authorization for Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), as a once-daily...
The FDA has approved supplemental applications for Sovaldi (sofosbuvir), from Gilead Sciences, to treat hepatitis C virus (HCV) in children...
The CHMP has given an opinion on the use of a fixed-dose combination of ledipasvir and sofosbuvir from Gilead Sciences...
Bristol-Myers Squibb announced that the FDA has accepted for filing and review three supplemental New Drug Applications (sNDAs) for Daklinza...
Bristol-Myers Squibb Company (BMS) announced that Daklinza (daclatasvir), an NS5A replication complex inhibitor, has been approved on 24 July 2015...
Gilead Sciences has submitted a New Drug Application (NDA) to the FDA for once-daily fixed-dose combination of Sovaldi + GS...