Pharming Group: FDA Acceptance Of Supplemental NDA, Priority Review For Leniolisib In Children With APDS
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Pharming Group NV PHARM:
PHARMING GROUP ANNOUNCES U.S. FDA ACCEPTANCE AND PRIORITY REVIEW OF SUPPLEMENTAL NEW DRUG APPLICATION FOR LENIOLISIB IN CHILDREN WITH APDS AGED 4 TO 11 YEARS
PDUFA TARGET ACTION DATE SET FOR JANUARY 31, 2026
DECISION BASED ON POSITIVE PHASE III STUDY DATA
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