DATA GRAPHICS | Data Byte
NME approvals off to slow start in 2024
FDA has approved just three NMEs so far this year, down from 10 at this time in 2023
March 13, 2024 11:34 PM UTC
After a banner 2023 in which FDA approved 55 new molecular entities (NMEs), the agency is off to a slow start in 2024, with only three NME approvals to date. At this time last year, the agency had approved 10.
Since 2018’s record of 59 NME approvals by FDA’s Center for Biologics Evaluation and Research (CDER), the fewest such approvals in any full quarter has been six, in 1Q18,1Q19 and 2Q22. That one of those slow quarters turned out to be part of the biggest year on record may bode well for 2024’s chances of picking up...