Posted by Michael Wonder on 09 Aug 2023
Galera receives complete response letter from US FDA for avasopasem manganese
9 August 2023 - The Company remains committed to its goal of bringing avasopasem manganese to patients and intends to meet with the FDA as soon as possible to discuss potential next steps.
Galera Therapeutics today announced that it has received a complete response letter from the US FDA regarding the Company’s new drug application for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard of care treatment.
