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FDA Starts 2015 As It Plans To Go On: A Spate Of Approvals, A Full Slate Of Possibilities

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

With more than 40 novel agents under FDA review – and seven approvals already – prospects are good for 2015 to be another stellar year for new molecular entity and novel biologic approvals. Supplemental indications with “breakthrough” designations and the first biosimilars could challenge the primacy of NMEs in the approval narrative.

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