Author Archives: Margarida Azevedo, MSc

FDA Accepts Catalyst’s NDA for Firdapse with Priority Review Status for LEMS

The U.S. Food and Drug Administration has accepted Catalyst Pharmaceuticals’ new drug application (NDA) for Firdapse (amifampridine phosphate) for Lambert-Eaton myasthenic syndrome (LEMS), with priority review status. Firdapse is a formulation of amifampridine phosphate in development for the treatment of LEMS as well as other conditions. Several clinical studies have…