FDA panel votes in favor of fecal transplant therapy for recurrent C. difficile infection

An FDA advisory committee recently voted there was adequate data to support the safety and efficacy of fecal microbiota transplant therapy Rebyota for the treatment of adult patients with recurrent Clostridioides difficile infection.Following a full day of discussion and presentations on the epidemiology of C. difficile infection (CDI) in the U.S. and available data on Rebyota (RBX2660, Rebiotix Inc.), the Vaccines and Related Biological Products Advisory Committee voted 13-4 in favor of the availability of adequate data supporting effectiveness and 12-4, with one abstention, in favor of theRead More

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