pakman schreef op 3 december 2025 09:43:
Pediatric Label Expansion
A supplemental New Drug Application for leniolisib in children aged 4 to 11 years with APDS has been accepted by the FDA, with a Priority Review and a PDUFA target action date of January 31, 2026. A commercial launch is planned for the first quarter of 2026, pending approval. In parallel, a Phase III trial in children aged 1 to 6 has completed enrollment, with results expected soon.
wist dit niet 1-6 jaar ook