Seladelpar NDA Submitted to FDA for Primary Biliary Cholangi

The New Drug Application submission is supported by data from a pair of phase 3 studies, a long-term open-label study, and prior phase 2 studies. Cymabay has also requested Priority Review of the NDA.

Related Keywords

, Klara Dickinson , Drug Administration , Cymabay Therapeutics , New Drug Application , Priority Review , Breakthrough Therapy Designation , Cymabay Submits New Drug Application , Primary Biliary , Primary Biliary Cholangitis Including Pruritus , Patients Without Cirrhosis , With Compensated , Improves Markers , Cymabay Therapeutics Announces Publication , Results From , Primary Biliary Cholangitis , Honda , Fda , Food And Drug Administration , Seladelpar , Cpbc , Pruritis ,