CNS Disorders
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Axsome Therapeutics Receives FDA Approval for AUVELITY to Treat Alzheimer's Agitation - First-in-Class Breakthrough
Axsome Therapeutics announces FDA approval of AUVELITY for Alzheimer's agitation, marking first-in-class treatment for critical unmet medical need.
FDA Places Clinical Hold on Newron's Evenamide Phase III Trial for Treatment-Resistant Schizophrenia
FDA halts enrollment in Newron's Phase III ENIGMA-TRS 2 study of evenamide for treatment-resistant schizophrenia, creating regulatory uncertainty for the novel therapy.
FDA Accepts Praxis Precision Medicines' New Drug Application for Ulixacaltamide HCl Essential Tremor Treatment
FDA accepts Praxis Precision Medicines' NDA for ulixacaltamide HCl essential tremor treatment with January 2027 PDUFA date, no advisory committee expected.