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U.S. FDA Gives Bristol-Myers' Hepatitis Drug "Breakthrough" Designation

February 26, 2014

This article was reported by Fox Business.

Fox Business reported that the U.S. Food and Drug Administration (FDA) awarded "breakthrough therapy designation" to Bristol-Myers Squibb's investigational treatment for hepatitis C virus (HCV) infection on February 24. This rare designation expedites the development and review process of drugs for serious or life-threatening conditions as FDA puts them on a fast-track approval process and gives the drug manufacturers intensive guidance. The approval for Bristol-Myers' combination therapy of chronic HCV infection comes after preliminary data from an ongoing late-stage trial in which the drug manufacturer is evaluating an all-oral regimen of daclatasvir and asunaprevir without ribavirin.

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