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Encore? FDA Could Come Close To Record 2012 NME Count This Year

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

With 19 novel agents approved so far in 2013 and a full slate of candidates under review, the recovery in novel agent approvals after the doldrums of the 2000s is likely to continue even if the agency falls short of last year’s 45 approvals. Watch for action on the first “breakthrough” therapies submitted and advances in hepatitis C treatment.


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