The FDA approved insulin icodec-abae for children 10+ with T2D, based on adult ONWARDS data and a single-dose pediatric pharmacokinetic study.
Feature|Articles|June 26, 2026
5 FDA decisions to watch for during 2H 2026
Author(s)Morgan Ebert, Executive Editor
Fact checked by: Benjamin P. Saylor
A preview of 5 pending FDA decisions for pediatric patients expected in the second half of 2026, spanning ADHD, psoriasis, a metabolic gene therapy, cardiomyopathy, and muscular dystrophy.
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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.
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