3 July 2019 - U.S. FDA accepts NDA for priority review.
RedHill Biopharma announced today that the U.S. FDA has accepted for review the new drug application for Talicia (RHB-105) for H. pylori infection.
The application for Talicia has also been granted priority review designation and was assigned a target Prescription Drug User Act action date by the FDA of 2 November 2019.