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DATA GRAPHICS | Data Byte

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

Subcutaneous formulations of Tecentriq and Ocrevus also among month’s seven new product approvals

October 4, 2024 10:39 PM UTC

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. ...

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