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FDA: Submissions, Approvals & Warnings

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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Kentucky Oncology Practice and its Manager Plead Guilty to Purchasing and Selling Unapproved Chemotherapy Drugs

Hematology and Oncology Center (HOC) PLLC of Somerset, Kentucky has pleaded guilty to federal charges that the firm purchased and sold unapproved and improperly labeled chemotherapy drugs. HOC’s former office

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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

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FDA Approves Xalkori for Late-stage Lung Cancer

The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic

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Arena Pharma Announces Phase 1 Results for APD811

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today results from a Phase 1 clinical trial of APD811, an orally bioavailable agonist of the prostacyclin receptor which is intended for the treatment

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