BioCentury
ARTICLE | Politics & Policy

NME approvals nearly doubled in 2017

December 20, 2017 7:42 PM UTC

FDA has approved 43 new molecular entities (NMEs) thus far in 2017. The figure is nearly twice 2016's 22 approvals, and is the second-highest total in the past 20 years. With a week and a half left in the year, 2017's tally still lags the 45 approvals in 2015.

FDA's accounting is for new drugs and biologics reviewed by the Center for Drug Evaluation and Research (CDER), so it does not include three cell and gene therapies approved this year. FDA's Center for Biologics Evaluation and Research (CBER) reviewed those products -- Kymriah tisagenlecleucel from Novartis AG (NYSE:NVS; SIX:NOVN), Yescarta axicabtagene ciloleucel from Gilead Sciences Inc. (NASDAQ:GILD) and Luxturna voretigene neparvovec-rzyl from Spark Therapeutics Inc. (NASDAQ:ONCE)...