ProMetic initiates rolling submission of its biologics license application for plasminogen with U.S. FDA

ProMetic Life Sciences

19 December 2016 - ProMetic Life Sciences announced today that it has initiated the rolling submission of its biologics license application for plasminogen with the U.S. FDA for treatment of patients with plasminogen congenital deficiency. 

ProMetic’s plasminogen was granted orphan drug and fast track designations by the FDA. The fast track designation allows rolling submissions of portions of the regulatory application to be submitted and reviewed by the FDA on an ongoing basis.

Read ProMetic Life Sciences press release


Michael Wonder

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Michael Wonder

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US , Submission , Blood product