The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Pharming Group’s Joenja (leniolisib) for activated PI3K‑delta syndrome (APDS) on March 26, 2026. The opinion clears the way for a European Commission decision, expected in the second quarter of 2026, and would make Joenja the first approved treatment for APDS in the European Union.
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Pharming Group N.V. secured regulatory approval in Japan for its oral PI3K‑delta inhibitor, Joenja (leniolisib), for the treatment of activated PI3K‑delta syndrome (APDS) in patients aged four years and older. The Ministry of Health, Labour and Welfare granted the approval on March 24, 2026, making Joenja the first targeted therapy for APDS available in Japan and the first drug approved worldwide for children 4‑11 with the condition.
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