November 13, 2017
Theratechnologies Announces Decision by the FDA to Extend the Ibalizumab Review Period to April 3, 2018
Theratechnologies Inc. (Theratechnologies) (TSX:TH) announced that it was notified today by its partner, TaiMed Biologics, Inc. (“TaiMed”), that the U.S. Food and Drug Administration (FDA) will extend its review of the Biologics License Application (“BLA”) for ibalizumab. In a notice received today by TaiMed from the FDA, the Prescription Drug User Fee Act (“PDUFA”) target action date has been extended to April 3, 2018. The three-month extension period is the FDA’s standard extension period.