The number of drug approvals was down by more than half from 1Q13. Registrations reflected the march of biobetter drugs (Tanzeum; Alprolix). A first-in-class phosphodiesterase E inhibitor was approved for psoriatic arthritis. The cardiology field received a huge setback, with negative opinions for Novartis' highly anticipated peptide relaxin (Reasanz) in acute heart failure. PDUFA dates are approaching for Gilead's idelalisib against phosphoinositol trisphosphate kinase and Mannkind's oral insulin.

Historic US regulatory approvals by drug class

Notable regulatory approvals (Q1 2014)

Notable regulatory setbacks (Q1 2014)

Notable upcoming regulatory decisions (Q3 2014)

Notable clinical trial results (Q1 2014)