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Posts Tagged 'US FDA'

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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