Among this quarter's new drugs are the first monoclonal antibody (mAb) therapies against programmed cell death inhibitor 1 (PD1), the first phosphoinositide 3-kinase (PI3k) inhibitor, an orexin inhibitor for insomnia and the first pan-histone deacetylase (HDAC) inhibitor approved in 5 years. Six drugs received breakthrough drug designations, with a rash of anti-fibrotic drugs. The first bona fide biosimilar application goes up for review by the US Food and Drug Administration (FDA) in the next quarter.

Notable regulatory approvals (3Q14)

Notable regulatory setbacks (3Q14)

FDA approvals by drug molecule type

Notable clinical trial results (3Q14)

Notable upcoming regulatory decisions (4Q14)