- The European Medicines Agency (EMA) accepts for review Gilead Sciences' (NASDAQ:GILD) Marketing Authorization Application (MAA) seeking approval of its once-daily single-table regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV) infection. The MAA has accelerated review status which shortens the review clock to 150 days from the usual 210 days.
- The company's marketing application in the U.S. is currently under FDA review.