Seres Therapeutics announces FDA acceptance of biologics license application for investigational microbiome therapeutic SER-109 for recurrent C. difficile infection for priority review

Seres Therapeutics

26 October 2022 - PDUFA target action date is 26 April 2023, with anticipated launch soon thereafter.

Seres Therapeutics today announced the US FDA has accepted for review a biologics license application for investigational oral microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection.

Read Seres Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier