Jan 6, 2026
NDA and Alzheimers
The FDA has accepted a supplemental New Drug Application (sNDA) for AXS‑05 to treat agitation in Alzheimer’s disease and granted Priority Review with a PDUFA action date of April 30, 2026, moving a co...
AXS-05 FDA Approval
Axsome Therapeutics' supplemental New Drug Application (sNDA) for AXS-05 to treat agitation in Alzheimer's disease has been accepted by the FDA with Priority Review and a target action date of April 30, 2026.