FDA news in pediatrics: October 2026

October's FDA pediatric news clustered around label expansions that extend already-approved adult or older-adolescent therapies down to younger age groups and formulations that ease dosing, alongside a Breakthrough Therapy designation for a rare dermatologic condition and continued movement on a long-delayed epinephrine alternative. Together, the month's items illustrate how the agency increasingly leans on extrapolated adult data and dosing/formulation studies, rather than dedicated pediatric efficacy trials, to broaden pediatric access.