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Regulatory Briefs: Novartis And GSK See Approvals, TMC And Acorda Don’t

Executive Summary

In a busy week for FDA drug approval actions, agency clears Novartis’ “breakthrough therapy” ceritinib for lung cancer and GlaxoSmithKline’s stand-alone COPD treatment umeclidinium but hands “complete response” letters to The Medicines Co. and Acorda Therapeutics.

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