The Priority Review

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BIZENGRI

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  1. Regulation

    FDA corrects patent extension review periods for six drugs

    The FDA corrects the length of the regulatory review period for ANDEMBRY, ANZUPGO, ANKTIVA, BIZENGRI, BRINSUPRI, and DAYVIGO due to calculation errors. The corrections apply to determinations announced on August 10, August 17, and September 9, 2026; no other changes are made.