Axsome receives FDA nod for Alzheimer’s agitation treatment

Axsome announced that the U.S. Food and Drug Administration granted it a nod for a therapy aimed at agitation associated with Alzheimer’s disease, according to the STAT+ report.

The decision marks a regulatory milestone for the company as it seeks to address a significant unmet need in dementia care, where agitation can lead to patient distress and caregiver burden.

The article also noted other industry updates, including the FDA’s appointment of Katherine Szarama as acting head of CBER and Julia Vitarello’s new initiative to scale bespoke medicines, underscoring ongoing changes in biotech leadership and strategy.