Posted by Michael Wonder on 24 Dec 2024
Tonix Pharmaceuticals announces PDUFA goal date of 15 August 2025 for FDA decision on US marketing approval for TNX-102 SL for fibromyalgia
23 December 2024 - New drug application based on two statistically significant Phase 3 studies of TNX-102 SL for the management of fibromyalgia, in which TNX-102 SL was generally well tolerated
Tonix Pharmaceuticals today announced that the US FDA assigned a PDUFA goal date of 15 August 2025, for a decision on marketing approval for TNX-102 SL (cyclobenzaprine hydrochloride sublingual tablets) for fibromyalgia.
