FDA drug approvals are on track with last year's tally by 2Q13. Apart from MannKind's inhaled insulin, Merck's PAR-1 antagonist with its potential safety benefit and long-acting versions of GLP-1 and Factor VIII were approved. A slew of hepatitis C drugs in various combinations is moving toward registration. New breakthrough drug designations include the first chimeric antigen receptor (CAR) T-cell therapy and gene therapy to receive the designation. This new category for drug review seems to be in favor both at the FDA and in companies.

Historic US regulatory approvals by lead indication area

Notable clinical trial results (2Q14)

Notable upcoming regulatory decisions (3Q14)

Notable regulatory approvals (2Q14)

Notable regulatory setbacks (2Q14)