Your trusted source for investing success

Tag: nda

Looking for Cannabis Stocks?

Read our report to find market data, important news and stocks to watch!

Akcea Announces FDA Advisory Committee Meeting to Review Volanesorsen

Akcea Therapeutics (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders, today announced that the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration (FDA) will hold an advisory committee meeting to review

Agios Reports Fourth Quarter and Full Year 2017 Financial Results

Agios Pharmaceuticals (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today reported business highlights and financial results for the fourth quarter and year ended December 31, 2017. In addition, Agios highlighted select 2018 corporate milestones and data presentations for its clinical development

Tetraphase Announces Top-Line Results from IGNITE3 Phase 3 Clinical Trial of Eravacycline

Tetraphase Pharmaceuticals (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that its IGNITE3 clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to ertapenem for the treatment of patients with complicated urinary tract infections (cUTI) did

Opiant Pharmaceuticals Announces Development of OPNT003

Opiant Pharmaceuticals (NASDAQ:OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions, today announced positive data from a Phase I clinical study of its product candidate OPNT003 and provided an update on a meeting held February 8, 2018 with the U.S. Food and Drug Administration (FDA) regarding its planned development

Pain Therapeutics Resubmits New Drug Application for REMOXY ER

Pain Therapeutics (Nasdaq:PTIE) announced today the resubmission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for REMOXY® ER, its lead drug candidate.  The Company expects a six-month review cycle by FDA.

As quoted in the press release:
Pain Therapeutics developed REMOXY ER as an abuse-deterrent, extended-release, capsule

Elite Pharmaceuticals and SunGen Pharma File ANDA

Elite Pharmaceuticals (OTCBB:ELTP) a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration (FDA) for a generic version of an immediate release CNS stimulant.

As quoted in the press release:
“The filing of

Nymox Announces US NDA for Fexapotide for BPH

Nymox Pharmaceutical (NASDAQ:NYMX) announced that the Company will submit a New Drug Application (NDA) for Fexapotide Triflutate for the treatment of BPH in the US.

As quoted in the press release:
The full results of the Company’s Phase 3 US trials were recently published in World Journal of Urology. World Journal of Urology is the

BeiGene Initiates Global Phase 3 Trial of Anti-PD-1 Antibody Tislelizumab in Patients with Esophageal Squamous Cell Carcinoma

BeiGene (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, today announced that the first patient was dosed in a global Phase 3 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, as a potential second-line treatment in patients with

Enter Your Log In Credentials
This setting should only be used on your home or work computer.


Privacy & Legal Policy

Privacy Policy

Investing News Network

Send this to a friend

I thought you might find this interesting:
Cannabis Weekly Round-Up: Two Provinces Reveal Deals in Place for Recreational Market