Through the first half of 2018, US Food and Drug Administration (FDA) approvals lagged relative to last year, but the agency's calendar looks busy ahead, with decisions for several acute myelogenous leukemia drugs in particular. Amgen's monoclonal antibody (mAb) Aimovig (erenumab) was approved for migraine; and there was a rash of approvals for both rare disorders (X-linked hyperphosphatemia; immune thrombocytopenic purpura; familial amyloidotic cardiomyopathy and phenylketonuria) and infectious diseases (urinary/reproductive tract infections and river blindness). Europe pulled conditional approval of Sarepta's exon-skipping drug, Exondys 51, for Duchenne muscular dystrophy; the FDA continues to monitor closely experimental gene-edited cell therapies being taken into the clinic.
Historic US regulatory approvals by lead indicationboxed-text
Notable regulatory setbacks (2Q18)boxed-text
Notable clinical trial results (2Q18)boxed-text
Notable regulatory approvals (2Q18)boxed-text
Notable upcoming catalysts (4Q18)boxed-text