FDA First-Half Approvals: 12 New Molecular Entities, 4 Biologics
This article was originally published in The Pink Sheet Daily
Executive Summary
The mid-year approval count puts the agency ahead of 2003's mid-year tally of nine NMEs, but behind the six biologics cleared in the first half of last year. FDA appears poised to beat 2003's full-year score of 21 NME approvals, with at least 32 NMEs pending.