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 acceler- ated 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.
Fonte: NATURE BIOTECHNOLOGY VOLUME 35 NUMBER 8 AUGUST 2017
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