Banner year for NMEs so far

FDA approved 26 new molecular entities in 1H23, one short of the record 27 approvals in 1H21. Two more products approved in July have brought this year’s total to date to 28— more than 2016’s full-year total and three quarters of 2022’s 37 approvals.

FDA has typically approved more NMEs in the second half of the year than in the first. In 1985-2022, 39% of approvals were granted in the first half, and 61% in the second half, of their respective years. If this trend continues, 2023 could see more than 70 approvals, well exceeding the record of 59 set in 1996 and repeated in 2018...