PerspectiveFeature2014 in review: FDA approval of new drugs

•FDA approved 42 new molecular entities in 2014, which is considerably higher than recent averages.•The diversity of targets recognized by newly approved drugs is more broad than ever.•The number of active and independent biotechnology companies shrank to levels not seen in decades.

The year 2014 witnessed the approval by the US Food and Drug Administration (FDA) of 42 new molecular entities (NMEs), which is well above recent averages. These molecules targeted a range of molecular pathways and clinical indications, although the latter was skewed toward hepatitis C virus (HCV) infection and diabetes. By contrast, a single drug was approved for cardiovascular diseases and none for neurological indications (excepting sleeping disorders). Of note is a continued trend toward consolidation because the net number of biotechnology companies has reached its lowest point in over 25 years, raising questions about sustainability.