Tonix Pharmaceuticals Holding Corp. has secured official marketing authorization and regulatory approval from the U.S. Food and Drug Administration for its proprietary drug candidate, Tonmya (cyclobenzaprine hydrochloride sublingual tablets), indicated for the management of fibromyalgia in adults. This pivotal regulatory milestone marked a massive achievement for the enterprise, establishing its sublingual tablet formulation as the first new approved pharmaceutical option specifically designed for fibromyalgia management in over fifteen years. The successful green light was backed by compelling data from multiple Phase 3 clinical trials demonstrating measurable improvements in daily pain scores and restorative sleep quality.