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Posts Tagged 'Food and Drug Administration'

Relmada Therapeutics Set for Busy 2015 in Clinical Trials Developing Drugs for the Lucrative Pain Market

Relmada Therapeutics Set for Busy 2015 in Clinical Trials Developing Drugs for the Lucrative Pain Market

Written by Ι Stock Market Media Group Staff — April 2, 2015

NEW YORK, NY – Relmada Therapeutics, Inc. (OTCQB: RLMD) has quite a busy 2015 ahead of it in the clinic. The pharmaceutical company has stepped up its work in a big way, and the latest news out of Relmada has it continuing to apply its unique model of drug development to “repurposed drugs” in the largest prescription drug market in the world – the pain market.

When Relmada received clearance from Health ...

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Nuvilex Announces Name Change to PharmaCyte Biotech

Nuvilex Announces Name Change to PharmaCyte Biotech

Company’s Shares Will Trade Under New Ticker Symbol PHCB

SILVER SPRING, MD., Jan. 7, 2015 — Nuvilex, Inc. (NVLX) today announced that the Company has changed its name to PharmaCyte Biotech, Inc. Shares in PharmaCyte Biotech will trade under the new ticker symbol “PHCB” on the OTCQB electronic platform. The new symbol is expected to become effective at the open of the market on January 8, 2014. The name change ...

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Nuvilex’s Cancer Treatment Obtaining FDA Orphan Drug Status Would Make Company Attractive Big Pharma Target

Written by Ι Stock Market Media Group Staff — October 14, 2014

New York, NY – Nuvilex, Inc. (OTCQB: NVLX) has officially introduced its advanced pancreatic cancer treatment to the U.S. Food and Drug Administration (FDA) in an application asking the agency to grant orphan drug status to its Cell-in-a-Box/ifosfamide combination for the rare disease.

The FDA’s orphan drug program designates a special status to drugs and biologics intended to treat, diagnose, or prevent diseases and disorders that affect fewer than 200,000 ...

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Nuvilex Applies to FDA for Orphan Drug Designation for Its Cell-in-a-Box Treatment for Pancreatic Cancer

Silver Spring, MD — October 13, 2014 — Nuvilex, Inc. (OTCQB: NVLX), a clinical-stage biotechnology company developing cell therapy solutions for the treatment of diseases, announced today that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for its Cell-in-a-Box® treatment for pancreatic cancer. If granted, Orphan Drug Designation in the United States will provide Nuvilex special development and commercial assistance from the FDA, including a 7 year period of marketing exclusivity. ...

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Nuvilex Eyes FDA Accelerated Approval Process by Improving Quality of Life in Pancreatic Cancer Patients

Nuvilex Eyes FDA Accelerated Approval Process by Improving Quality of Life in Pancreatic Cancer Patients

Written by ι Stock Market Media Group Staff — May 23, 2014

Nuvilex (OTCQB: NVLX) is calling it a “two pronged attack” on pancreatic cancer, but investors may be calling it an “end-around” or another avenue of sorts, a quicker avenue to FDA approval.  This week Nuvilex peeled back another layer of its work with pancreatic cancer, and this time it was to tell the market that the well-respected Translational Drug Development (TD2) will be studying the company’s pancreatic cancer treatment, the combination ...

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