Axsome Secures FDA Nod for Alzheimer’s Agitation
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- Axsome receives FDA approval for its Alzheimer’s agitation treatment, marking the first such therapy to clear the regulator’s review.
- Katherine Szarama serves as acting head of the FDA’s Center for Biologics Evaluation and Research (CBER) while the agency seeks a permanent leader.
- Julia Vitarello launches a new effort to scale bespoke medicines after her first startup faltered, aiming to accelerate personalized therapy development.
- Matt Herper reflects on J. Craig Venter’s influence, noting how his genomics breakthroughs continue to shape biotech innovation.
Why it matters: Alzheimer’s patients gain one new therapy option, while Axsome’s shareholders anticipate revenue growth; the approval also spurs competition, prompting rivals to accelerate their neuropsychiatric pipelines.
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