The fourth quarter was a busy time at the US Food and Drug Administration (FDA), with a slew of approvals, including the first bispecific antibody and two drugs approved on the same day for idiopathic pulmonary fibrosis, a previously untreatable disease. Breakthrough drug designations now number 60, with more than a dozen getting through to approval. The first quarter, though, looks to be a quiet one at the FDA, although the European Medicines Agency (EMA) will be looking at some novel cell therapies.

Top ten disease groups by pipeline size

Notable regulatory approvals (4Q14)

Notable upcoming regulatory decisions (1Q15)

Notable regulatory setbacks (4Q14)

Notable clinical trial results (4Q14)