Ferring Pharmaceuticals has the distinction of winning the first US Food and Drug Administration approval for a microbiota-based drug, just a day after the agency issued a final guidance that should help it on the market by limiting use of unregulated microbiome products. An analyst said the approval resolves significant overhang for the microbiome space, but also that the future could be in more targeted therapies.
The FDA approved Ferring subsidiary Rebiotix’s Rebyota (fecal microbiota, live-jslm) for preventing recurrence of Clostridioides difficile infection
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