The US Food and Drug Administration (FDA) approved its first three breakthrough designation (BTD) drugs; promising phase 2 data were reported for several other BTD drugs in hepatitis C. The last quarter of 2013 was also significant for the approval of two new drugs for pulmonary hypertension. Regulators gave negative decisions on Lemtrada (alemtuzumab) in multiple sclerosis and masitinib for gastrointestinal tumors. Early 2014 will be a busy time for the FDA as a large number of new medical entities (NMEs) have PDUFA dates.

BLA, biologic license application; NDA, new drug application

Notable regulatory approvals (Q4 2013)

Notable regulatory setbacks (Q4 2013)

Notable clinical trial results (Q4 2013)

Notable upcoming regulatory decisions (Q2 2014)