US Food and Drug Administration approvals continue to lag behind the European Medicine Agency (EMA), particularly with the US government shutdown; 2013 is shaping up as a very poor year for first-in-class drug approvals. EMA approved the first biosimilar monoclonal antibody; Biogen, Pharmacyclics, Clinuvel, Actelion and Celgene all await final regulatory decisions.

Notable clinical trial results (Q3 2013)

Notable upcoming regulatory decisions (Q1 2014)

FDA approvals by drug molecule type

Notable regulatory approvals (Q3 2013)

Notable regulatory setbacks (Q3 2013)