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FDA has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials. PDUFA date extended to Oct 23 2016

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The FDA granted Priority Review designation to the bezlotoxumab BLA, with an original PDUFA goal date of July 23, 2016. On June 9, the Antimicrobial Drugs Advisory Committee of the FDA voted 10-to-5, with one abstention, in support of bezlotoxumab as showing substantial evidence of efficacy and safety in preventing the recurrence of C. difficile infection.
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Related Keywords Clostridium Difficile, C. Difficile, Infection Recurrence, Bla