Axsome’s Alzheimer’s Agitation Drug Wins FDA Approval; FDA Appoints Katherine Szarama Acting CBER Chief
Fast facts
- Category: Health
- Language: EN
- Published: 2026-05-01 10:08 UTC
- Sources: Stat News
The FDA has granted approval to Axsome Therapeutics’ new medication for agitation associated with Alzheimer’s disease, marking a rare approval in this therapeutic area. In the same announcement, the agency named Katherine Szarama as the acting head of the Center for Biologics Evaluation and Research (CBER) after a leadership vacancy. Both actions were reported by Stat News; no conflicting details were noted across sources.