Bezlotoxumab regulatory update

FDA’s Antimicrobial Drugs Advisory Committee will meet on June 9 to discuss a BLA from Merck for bezlotoxumab to prevent recurrence of Clostridium difficile infection. The human mAb targeting C. difficile toxin B ( TcdB) is under Priority Review, with a July 23 PDUFA date. An MAA for bezlotoxumab is also under EMA review. ...