The U.S. Food and Drug Administration officially granted full marketing approval to Tonmya, which is formulated as cyclobenzaprine hydrochloride sublingual tablets developed by Tonix Pharmaceuticals, for the clinical treatment of fibromyalgia in adults. This regulatory green light marked a major corporate and medical milestone, establishing Tonmya as the first new FDA-approved pharmaceutical option specifically indicated for fibromyalgia management in over fifteen years. The approval was supported by robust data from multiple pivotal Phase 3 clinical trials demonstrating significant reductions in daily pain scores and meaningful improvements in patient sleep quality.