Cystic Fibrosis Treatment Granted FDA Orphan Drug Status

Colorado-based Nivalis Therapeutics recently announced the U.S. Food and Drug Administration (FDA) has granted the company’s lead clinical candidate, N91115, Orphan Drug Designation for the treatment of cystic fibrosis (CF). The designation gives Nivalis exclusive marketing for seven years against competition and includes incentives such as tax credits, federal grants, and a waiver of filing fees required under the Prescription Drug User Fee Act.  CF…

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