Abstract: Objective：To provide information for drug regulators and new drug researchers by analysing new drugs approved by the U.S. Food and Drug Administration（FDA） in 2014. Methods：We retrieve the data issued in FDA official website，and analysis the basic situation of the new drugs approved in U.S. Results and Conclusion：FDA approved a total of 41 novel new drugs，know as new molecular entities (NMEs) in 2014, including 30 new drug applications (NDAs) and 11 new biological applications (BLAs). Approvals were up by over 50% from the 27 approved in 2013, and up 30% from the 5-year average of 31.6 per year. The number of NMEs applications in 2014 with 36 applications was overall relatively stable. 2014 was the biggest year to date for first-in-class and orphan-drug approvals, with 17（41%） first-in-class and 17 (41%) orphan designees in the approval cohort. 9 NMEs had breakthrough-therapy designation. The current focus for drug R