FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and announce whether Priority Review ...

FDA accepts Tonix’s NDA for TNX-102 SL, a non-opioid fibromyalgia treatment. Learn how this potential new drug addresses ...

Tonix Pharmaceuticals (TNXP) announced that the U.S. Food and Drug Administration, FDA, has accepted the filing of its New Drug Application, ...

Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) shares are trading lower Tuesday after initially jumping after the company ...

Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 ...

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCL sublingual tablets) for the management of fibromyalgia.

Tonix expects to hear a decision on NDA acceptance by the FDA in mid-December. If the NDA is accepted, Tonix said the FDA could commit to a decision on approval in 2025, which means TNX-102 SL ...

Tonix expects to hear a decision on NDA acceptance by the FDA in mid-December. If the NDA is accepted, Tonix said the FDA could commit to a decision on approval in 2025, which means TNX-102 SL could ...