FDA approves Spravato as monotherapy for adults with major depressive disorder
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as monotherapy for adults with treatment-resistant depression, Johnson & Johnson announced in a press release.
JNJ's SNDA For Spravato Monotherapy Gets FDA Approval For Treatment-Resistant Depression
Tuesday announced that the U.S. Food and Drug Administration has approved supplemental New Drug Application or sNDA for Spravato, a monotherapy for adults with treatment-resistant depression, a psychiatric disorder.
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...
PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a $77.5 million market cap company known for its focus on non-opioid pain management products, reported that the U.S. Food and Drug ...
The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.
The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...
Cybin updated the market with impressive 12-month efficacy data for its CYB003 Phase 2 trial. Explore more details here.
An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time ...
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