Posted by Michael Wonder on 02 May 2022
Axsome Therapeutics receives FDA complete response letter for new drug application for AXS-07 for the acute treatment of migraine
2 May 2022 - No clinical efficacy or safety issues raised and no additional clinical studies required by FDA to support approval.
Axsome Therapeutics today announced that the Company has received a complete response letter from the U.S. FDA regarding its new drug application for AXS-07 for the acute treatment of migraine.
