Last minute flurry brings FDA’s first-quarter NME approvals to 10

Highlights include accelerated approval of first MASH therapy; plus Merck’s disease-modifying PAH therapy and Idorsia’s antihypertensive 

April 3, 2024 1:01 AM UTC

After a slow start to the year, a flurry of approvals in March brought the total number of new molecular entities approved by FDA from three to 10 by the end of the quarter, putting 1Q24 in the range of past quarters, and avoiding a new record low. 

FDA approved 10 NMEs in total in the first quarter, seven of which came in the past three weeks, including three of the quarter’s highest-profile decisions. ...