Tonix Pharmaceuticals (TNXP) announced that the U.S. Food and Drug Administration will not require an Advisory Committee meeting to discuss the Company’s New Drug Application for TNX-102 SL for the management of fibromyalgia. If approved, TNX-102 SL would be the first new treatment option for fibromyalgia patients in 15 years. The FDA previously granted Fast Track designation to TNX-102 SL for the management of fibromyalgia in 2024, a designation intended to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.
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