RedHill Biopharma Ltd. announced that the U.S. FDA has accepted for review the New Drug Application (NDA) for Talicia (RHB-105)1 for H. pylori infection. The NDA for Talicia has also been granted Priority Review designation and was assigned a target Prescription Drug User Act (PDUFA) action date by the FDA of November 2, 2019. Commercial launch of Talicia with RedHill’s existing U.S. sales force is planned shortly following potential FDA approval. If approved, Talicia would be eligible for ...