US FDA Acceptance For Priority Review Of New Drug Application For Leniolisib

Pharming

28/09/2022 06:03

Sept 28 (Reuters) - Pharming Group NV  PHAR.AS :
    * PHARMING ANNOUNCES US FDA ACCEPTANCE FOR PRIORITY REVIEW
OF ITS
NEW DRUG APPLICATION FOR LENIOLISIB
    * FDA HAS ASSIGNED A PDUFA GOAL DATE OF MARCH 29, 2023 FOR
NDA
SUBMISSION BASED ON RANDOMIZED-CONTROLLED AND LONG-TERM
EXTENSION DATA FOR LENIOLISIB AS A TREATMENT FOR APDS, A RARE
PRIMARY IMMUNODEFICIENCY

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