Tonix Pharmaceuticals, food and drug administration

Tonix Pharma Stock’s Retail Chatter Explodes After FDA Nod For New Drug Application
Tonix Pharmaceuticals was the most active symbol on Stocktwits before the bell on Wednesday as shares of the clinical-stage biopharmaceutical company surged over 35% in premarket after witnessing a significant decline on Tuesday.
Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia
FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and announce whether Priority Review has been granted in
Tonix Pharmaceuticals Gets FDA Review of Fibromyalgia Drug
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.
Sobi Announces FDA Acceptance of New Drug Application for Avatrombopag (DOPTELET®) for the Treatment of Pediatric Immune Thrombocytopenia
The FDA also accepted Sobi's New Drug Application (NDA) for avatrombopag for oral suspension. Avatrombopag for oral suspension is a capsule where its granules are sprinkled onto a soft food or liquid to prepare for administration.
FDA accepts Tonix’s NDA for non-opioid fibromyalgia drug TNX-102 SL
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for TNX-102 SL, a non-opioid, centrally acting analgesic designed for fibromyalgia management.
East Bay aging-focused drug company lands new partner, potential half-billion-dollar payout
The Richmond company (Nasdaq: BIOA) will get a fraction of the money upfront from Novartis (NYSE: NVS) — up to $20 million, ...
FierceBiotech2d
Where is AI winning in drug discovery? 4 use cases to know
Even though AI-designed drugs aren’t yet a household term for FDA-approved, commercially available therapies, they are a ...
Yahoo Finance1mon
PharmaTher Announces Update on FDA New Drug Application for Ketamine
for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. The Company has initiated activities ...
Weight loss drugs could help end obesity - but risks remain, WHO says
LONDON - A new class of weight loss drugs developed by Novo Nordisk and Eli Lilly “opens the possibility of an end to the ...
Gelteq receives FDA approval of its suitability petition for new animal drug
Limited announces that the U.S. Food and Drug Administration, FDA, has approved its suitability petition for a new animal drug ...
Neurizon Files IND Application to Support HEALEY ALS Platform Trial
(ASX: NUZ & NUZOA) ("Neurizon" or "the Company"), a clinical-stage biotech company advancing treatments for neurodegenerative diseases, is pleased to announce the filing of an Investigational New Drug ...
Deccan Herald1d
Granules India gets USFDA nod for generic drug
Granules Pharmaceuticals, Inc (GPI) has received approval from the US Food & Drug Administration (USFDA) for its abbreviated ...