FDA’s September approvals include firsts for schizophrenia, Niemann-Pick

FDA approved four new molecular entities and three biologics in September, ushering in the first new mechanism to treat schizophrenia in decades and a pair of therapies for the ultra-rare disease Niemann-Pick type C.

The Sept. 26 approval of Cobenfy xanomeline-trospium, formerly known as KarXT, from Bristol Myers Squibb Co. (NYSE:BMY), established the product as first in a new class of agents targeting cholinergic receptors; several others in class are in development behind Cobenfy. ...