FDA Expands Joenja to Younger Children

Evidence Regulatory approval · Discovery September 12, 2026 · Importance 5/5 · Direction Positive Summary FDA approved Joenja, leniolisib, for children aged four through eleven years with activated phosphoinositide 3-kinase delta syndrome who weigh at least 27 kilograms. The 40-milligram and 50-milligram twice-daily doses make…