
FDA ApprovedUnited States
First FDA-Approved Pill for Children 4–11 With APDS
Joenja (leniolisib) — first labelled oral treatment for children 4–11 with APDS who weigh at least 27 kg
FDA supplemental approval on 11 September 2026 for Joenja (leniolisib) tablets — expanding the labelled APDS door to adult and pediatric patients 4…
This is for caregivers of children 4–11 years with genetically confirmed APDS who weigh at least 27…