美国食品和药物管理局接受了TNX-102 SL新药申请, The FDA accepted a new drug application for TNX-102 SL, a non-opioid treatment for fibromyalgia, first in 15 years.

美国食品和药物管理局已接受Tonix制药公司的TNX-102 SL申请,这是一种治疗纤维肌痛的非阿片类药物,这是15年来该病的首个新药申请. The FDA has accepted Tonix Pharmaceuticals' application for TNX-102 SL, a non-opioid drug to treat fibromyalgia, marking the first new drug application for the condition in over 15 years. 该药物如获批准,可为影响超过1 000万美国人的慢性疼痛症提供新的治疗选择。 The drug, if approved, could offer a new treatment option for the chronic pain disorder affecting over 10 million Americans. 美国食品和药物管理局将审查申请并确定目标行动日期,批准可能在2025年. The FDA will review the application and set a target action date, with approval potentially coming in 2025.