Regulated Information – Inside Information – UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that they were unable to complete review of the Biologics License Application (BLA) for bimekizumab for the treatment of moderate to severe plaque psoriasis by the Prescription Drug User Fee Action (PDUFA) date of Oc
The FDA is deferring action on the Biologics License Application for bimekizumab for moderate to severe plaque psoriasis due to COVID-19 related travel restrictions precluding an on-site facility inspection.