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Regulation

May 27 Quick Takes: EMDAC votes narrowly in favor of Provention’s teplizumab; plus BMS, Biohaven, Day One, Frazier, miRecule, Oisin and more

May 28, 2021 | 1:22 AM GMT

Ahead of teplizumab’s July 2 PDUFA date, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-7 in favor of approving the anti-CD3 mAb from Provention Bio Inc. (NASDAQ:PRVB) to delay Type I diabetes in at-risk individuals. The vote suggests a clearer path to approval than might have been expected

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