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FDA Announces Regulatory Review Period for Schizophrenia Drug Cobenfy
February 06, 2026

WASHINGTON, Feb. 6 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued a notice establishing the regulatory review period for the human drug product Cobenfy. This determination is a necessary step for the U.S. Department of Commerce Patent and Trademark Office to process patent term extension applications submitted by PureTech Health LLC.

Cobenfy is indicated for the treatment of schizophrenia in adults. The Agency determined that the tota . . .

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