Posted by Michael Wonder on 15 Feb 2023
Galera announces FDA acceptance and priority review of avasopasem NDA for radiotherapy induced severe oral mucositis
15 February 2023 - PDUFA target date of 9 August 2023.
Galera Therapeutics today announced that the US FDA has accepted for filing and granted priority review to the new drug application for avasopasem manganese for radiotherapy induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment.
