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 approved APDS pathway to adult and pediatric patients 4 years of…
This is for caregivers of children 4–11 years with genetically confirmed APDS who weigh at least 27 kg (about 60 lb) and who may be candidates for labelled US…