Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long needed treatments, such as sickle cell disease and postpartum depression. Highlights in Europe and China included several approvals of new targeted cancer therapies.

CDER approved 48 new molecular entities this year, down from 2018’s record-setting 59 approvals but ahead of 2017’s 46. Not included in those counts were CBER’s approvals, which included the first gene therapy for spinal muscular atrophy and vaccines for Ebola and Dengue (see “FDA Closes 2018”)...