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Regulators cleared the first non-antipsychotic drug for dementia-related agitation
Adults living with Alzheimer’s-related dementia now have a second FDA-approved drug for agitation, and for the first time, ...
Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. In August, the Food and Drug Administration (FDA) approved Axsome ...
Axsome Therapeutics’ AXSM Auvelity (AXS-05) was launched in the United States in 2022 for the treatment of major depressive disorder (MDD), making it the first approved drug in the company’s portfolio ...
In May 2026, Auvelity was approved by the Food and Drug Administration (FDA) to treat agitation associated with dementia and Alzheimer’s disease. Auvelity is the first oral, non-antipsychotic ...
AUVELITY is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week1-4 AUVELITY ...
Add Yahoo as a preferred source to see more of our stories on Google. The sub-study examined the impact of the therapy on prespecified Alzheimer’s plasma biomarkers in the subjects. Credit: Chinnapong ...
Auvelity (dextromethorphan/bupropion) is a prescription drug that’s used to treat depression and agitation related to dementia due to Alzheimer’s disease in ...
A new antidepressant drug is coming to the market, and analysts say it could disrupt the mental health landscape. On August 19, the FDA approved Axsome Therapeutics' drug Auvelity for the treatment of ...
First, a bit of background on Axsome. Its focus is on developing treatments for central nervous system conditions, and it has a pipeline of drug candidates targeting migraine, Alzheimer's disease ...
An Axsome Therapeutics depression drug designed to start working quickly now has its long-awaited approval one year after the target date for an FDA decision. The regulatory nod announced Friday makes ...
It's been 15 months since the FDA began an expedited review of the drug formerly known as AXS-05 that was supposed to be much shorter. First, there was a common manufacturing issue the company needed ...
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