Liminal BioSciences announces FDA extension of review period for Ryplazim (plasminogen) BLA

Liminal BioSciences

9 November 2020 - PDUFA date extended by FDA from 5 March 2021 to 5 June 2021.

Liminal BioSciences today announced that the U.S. FDA has notified the Company that it has extended the review period for the biologics license application for Ryplazim (plasminogen) for the treatment of clinical signs and symptoms associated with congenital plasminogen deficiency.

Read Liminal BioSciences press release

Michael Wonder

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Michael Wonder

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US , Timelines , Dossier , Blood product