Prometic announces FDA acceptance of its biologics license application for plasminogen (Ryplazim)

ProMetic Life Sciences

13 October 2017 - Ryplazim previously granted fast track, rare paediatric disease and orphan drug designations by U.S. FDA.

Prometic Life Sciences today announced that the U.S FDA has accepted its biologics license application for its plasminogen replacement therapy (Ryplazim) having granted a priority review status and set a Prescription Drug User Fee Act action date for 14 April 2018.

Read Prometic Life Sciences press release

Michael Wonder

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Michael Wonder

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US , Dossier , Blood product