FDA advisory committee votes for approval of first microbiome-based drug, despite data problems

Rebiotix’s microbiota-based RBX2660 could secure FDA approval to reduce C. difficile infection (CDI) recurrence, following a positive vote from the agency’s advisory committee. The FDA is due to rule on the live biotherapeutic — made from human stool — by mid-November, positioning it to potentially become the first microbiome-based drug to get the regulatory nod in the USA…

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Fonte: 786 | november 2022 | volume 21 news in brief www.nature.com/nrd