FDA approvals continue the upward trend noted in the first quarter, with the registration of the first deuterated compound, a new small-molecule drug for amyotrophic lateral sclerosis (ALS) and accelerated approval of Imfinzi, a checkpoint inhibitor for use in bladder cancer. A slew of drugs gained breakthrough therapy designation (Supplementary Table 1). The first approved gene therapy Glybera was axed for economic reasons; two biosimilars ran into trouble at the FDA.

Historic US regulatory approvals by lead indication

Notable upcoming catalysts (3Q17)

Notable setbacks (2Q17)

Notable approvals (2Q17)a

Notable clinical trial results (2Q17)