Just before the holiday break, the FDA put an exclamation point on the number of new molecular entity (NMEs) approvals this year with two more medicines crossing the goal line. At the end of November, the count had ticked to 54 following the green light for Coral Gables, Fla.-based Catalyst Pharmaceuticals Inc.'s Firdapse (amifampridine phosphate), the first drug designated in the U.S. to treat adults with Lambert-Eaton myasthenic syndrome. (See BioWorld, Nov. 30, 2018.)