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Pharming Group: FDA Acceptance Of Supplemental NDA, Priority Review For Leniolisib In Children With APDS

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PHARM

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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