5 FDA decisions to watch for during 2H 2026

After a first half of 2026 that brought historic firsts for Menkes disease, arginase 1 deficiency, achondroplasia, plaque psoriasis, and the neurologic complications of Hunter syndrome, the FDA's pediatric pipeline shows no signs of slowing. The back half of the year carries a slate of priority review decisions spanning neurodevelopmental, cardiac, metabolic, and neuromuscular disease—several of which could establish the first pharmacologic options ever available to the children and adolescents they're intended to treat.