Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib ...Middle East

The FDA has assigned a PDUFA goal date of March 29, 2023 for the NDA submission based on randomized-controlled and long-term extension data for leniolisib as a treatment for APDS, a rare primary immunodeficiency LEIDEN, The Netherlands, Sept. 28, 2022 /PRNewswire/ -- Pharming Group N.V....

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Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib ...Middle East

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