21 September 2020 - FDA assigns PDUFA target action date of 5 March 2021.

Liminal BioSciences announced today that the U.S. FDA acknowledged receipt of the resubmission, by its US subsidiary, Prometic Biotherapeutics of the biologic license application for Ryplazim (plasminogen) for the treatment of clinical signs and symptoms associated with congenital plasminogen deficiency in paediatrics and adults. 

The FDA confirmed that the resubmission is a complete, Class 2 response and has provided a Prescription Drug User Fee Act target action date of March 5, 2021.

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