2015 in review: FDA approval of new drugs

•The FDA approved 45 NMEs, with more than half for orphan indications.•The NMEs targeted a diverse array of targets and indication.•Consolidation reduced biotechnology companies to levels not seen since 1985.

The myriad new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2015 reflected both the opportunities and risks associated with the development of new medicines. On the one hand, the approval of 45 NMEs was among the highest ever recorded. Likewise, the diversity underlying the mechanistic basis of new medicines suggests continued broadening relative to the predominate trends of the past few decades. On the other hand, closer inspection indicates that business model decisions surrounding orphan indications and consolidation could be placing the industry in an ever-more precarious position, with severe implications for the sustainability of the entire enterprise.