The first quarter saw the first ever biosimilar approval in the United States. In addition, breast cancer patients have gained a first-line drug with a new mechanism of action. Several new treatments for hypocholesterolemia did well in clinical trials. And companies are having continued success gaining breakthrough drug designations. Dendritic cancer vaccine trial halted; peptide vaccine awaits approval.

Historic US regulatory approvals by drug class

Notable clinical trial results (1Q15)

Notable regulatory approvals (1Q15)

Notable regulatory setbacks (1Q15)

Notable upcoming regulatory decisions (2Q15)