new drug application - Search News

New Drug Application, Tonix Pharmaceuticals

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.

Business Insider · 1d

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

invezz on MSN · 1d

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.

MarketWatch · 1d

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.

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 ...

Stockhead on MSN15h

Neurizon files key IND application with US FDA for motor neurone disease drug

Pending FDA clearance of the IND application, Neurizon said it anticipated Massachusetts General Hospital filing a protocol ...

1hon MSN

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 ...

14h

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 ...

Montco cannabis company takes different path for approval of autism drug

Executives at a local company believe they have a quicker and less expensive path to get their new drug approved.

11don MSN

New method of drug discovery and development offers better understanding of how drugs work

According to a new study published in Nature Communications, researchers at the Department of Laboratory Medicine, Karolinska ...

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 ...

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 ...

Some results have been hidden because they may be inaccessible to you

Show inaccessible results