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FDA Drug Approvals

D.C. Week: Second PCSK9 Inhibitor Wins FDA Approval

ALSO: CMS targets wasteful spending in nursing facilities WASHINGTON — This week in the District, Amgen won approval for a new lipid-lowering drug, the PCSK9 inhibitor evolocumab (Repatha). Alirocumab (Praluent),

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Published Report: FDA on GDUFA

The FDA has released its Performance Report for the first year of the Generic Drug User Fee Amendments (PDF downloadable at http://1.usa.gov/1dquler).

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