Posted by Michael Wonder on 06 Jun 2023
SpringWorks Therapeutics announces PDUFA date extension for nirogacestat NDA
5 June 2023 - FDA extending PDUFA date by three months to allow more time to complete their review; new PDUFA date set to 27 November 2023.
SpringWorks Therapeutics announced today that the US FDA has updated the PDUFA action date for the new drug application for nirogacestat for the treatment of adults with desmoid tumours.
