Brief analysis on new drugs approved by FDA in 2016
YOU Jia
JIANG Zheng-yu
ZHANG Lian-shan
YOU Qi-dong
Abstract：The U.S.Food and Drug Administration (FDA) approved 22 new drugs in 2016,including 15 new molecular entities (NMEs) and 7 new biological applications (BLAs),much less than those approved in the last two years.Among these approvals,16 first-in-class drugs and several potential blockbusters,including the first small molecule protein-protein interaction inhibitor,the first PD-L1 antibody and the first drug to treat all six major forms of hepatitis C virus,together confirmed the innovation of these new drugs.Besides,more than 70％ of new drugs benefited from the specialized designations,facilitating and expediting development and review of new drugs to address unmet medical need.Although the number of new drugs approved in 2016 showed a decline,the quality remains high standard,further stressing the core role of creativity in new drug R&D filed.
Keywords：new molecular entitynew drug approvalFDA
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1225-1230 )