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

Tonix Pharma ( (TNXP) ) has provided an announcement.

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

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

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.

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Corp. with ...

Tonix Pharmaceuticals Holding said the Food and Drug Administration has accepted its application seeking approval of its TNX-102 SL product candidate for the chronic pain condition fibromyalgia.

Click here for a 6-minute video of Seth Lederman, MD, reviewing the status of TNX 102-SL for fibromyalgia Opioids come with their own set of problems. Opioids can be addictive and, over time ...

If the NDA is accepted, Tonix said the FDA could commit to a decision on approval in 2025, which means TNX-102 SL could be on the market as early as next year, giving fibromyalgia sufferers a much ...