NME approvals by FDA’s CDER reach 37, tying 2022

With Tuesday’s approval of Redemplo to treat familial chylomicronemia syndrome, FDA’s new molecular entity approvals stand at 37 for the year. While behind several recent years, 37 ties the full-year total for 2022, and far exceeds 2016’s 22 total.

Approvals have frequently been backloaded in the past six weeks of the year. Since 2016, a median of 15% of the total approvals came between Nov. 19 and Dec. 31. A similar pattern would put the 2025 total at 44. Last year saw 22% of the approvals in that time frame, jumping from 39 at Nov. 18 to 50 by year-end. ...