Consumer News Fda Approves First Digital Treatment For Depression
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FDA approves Caplyta for major depressive disorder in adults
The U.S. Food and Drug Administration has approved Caplyta (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder in adults. Read More
FDA clears first digital treatment for depression, but experts caution that research is still early

The US Food and Drug Administration is allowing the use of Rejoyn, the first prescription digital treatment for major depressive disorder. Rejoyn, made by Otsuka Pharmaceutical and Click Therapeutics, ... Read More
FDA approves J&J’s antipsychotic drug to treat depression

Damian Garde is a reporter at large, live and feature journalism, covering the global drug industry and contributing to STAT’s industry-leading events. Johnson & Johnson won U.S. approval to sell the ... Read More
FDA’s Digital Health Advisory Committee Considers Generative AI Therapy Chatbots for Depression

While the FDA has approved digital mental health solutions in recent years, including apps with solutions involving cognitive behavioral therapy (CBT), the agency has yet to clear mental health tools ... Read More
FDA approves new device for teens with severe depression

The FDA has approved Transcranial Magnetic Stimulation (TMS), a non-drug, magnetic pulse device, for use in teens as young as 15 to treat severe depression. TMS is now an option for adolescents who ... Read More
Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder

Tonix plans to initiate potential pivotal Phase 2 HORIZON study of TNX-102 SL in adults with major depressive disorder in mid-2026More than 21 ... Read More
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