Amgen's Repatha (evolocumab) antibody against PCSK9 is approved just one month after Sanofi's Praluent (alirocumab). More combination treatments continue to reach the market, including Orkambi (ivacaftor and lumacaftor) for cystic fibrosis and Entresto (sacubitril and valsartan) for congestive heart failure. In the coming months, the US Food and Drug Administration is slated to make decisions on several biosimilars, including the first monoclonal antibody (in the US). Also coming before the FDA will be the first and somewhat controversial oncolytic virus.

FDA approvals by drug type

Notable clinical trial results (3Q15)

Notable regulatory setbacks (3Q15)

Notable regulatory approvals (3Q15)

Notable upcoming regulatory decisions