With the FDA closing out the month of November with three approvals in the last week – Vitrakvi (larotrectinib) from Bayer AG and Loxo Oncology Inc., Xospata (gilteritinib) from Astellas Pharma Inc. and Firdapse (amifampridine phosphate) from Catalyst Pharmaceuticals Inc. – the industry surpassed the high-water mark for the number of new molecular entities (NMEs) approved in one year in the U.S., previously set in 1996 when the agency approved 53 NMEs.