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Metabolic Disorders Gynecology & Urology Infectious Diseases

2013 was springboard for 'breakthrough' drugs

This article was originally published in Scrip

Executive Summary

While the FDA's Center for Drug Evaluation and Research (CDER) approved 12 fewer new molecular entities (NMEs) and new therapeutic biologics in 2013 than it did in 2012 – 27 versus 39, respectively – the past year served as a springboard for the agency's new breakthrough therapy designation, with three medicines with the new status among the products gaining the agency's blessing to enter the US market.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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