FDA sets Seres on the priority review path for its microbiome C. difficile drug, setting up April decision
Though several companies have been looking at new drugs and candidates to go after C. difficile, one biotech is at the FDA’s doorstep.
Seres Therapeutics announced Wednesday morning that the federal regulatory agency accepted its BLA for SER-109, the biotech’s microbiome candidate to prevent recurrent C. difficile infection (rCDI). FDA gave a PDUFA date of April 26, and according to the biotech, the agency is not planning on an adcomm.
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