Brief: Pharming Group updates on EMA regulatory review of leniolisib MAA

Pharming

10/11/2023 13:56

Nov 10 (Reuters) - Pharming Group NV  PHAR.AS :
    * PHARMING GROUP PROVIDES UPDATES ON EMA REGULATORY REVIEW
OF
LENIOLISIB MAA AND PLANS TO FILE FOR UK REGULATORY APPROVAL
    * HAS RECEIVED A DAY 180 SECOND LIST OF OUTSTANDING ISSUES
(LOOI)
FROM EUROPEAN MEDICINES AGENCY'S (EMA) COMMITTEE FOR HUMAN
MEDICINAL PRODUCTS (CHMP
    * PHARMING NOW EXPECTS CHMP TO ISSUE ITS OPINION ON
LENIOLISIB MAA
IN Q1 OF 2024.
    * PHARMING NOW INTENDS TO FILE AN MAA WITH U.K. MEDICINES
AND
HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) THROUGH
INTERNATIONAL RECOGNITION PROCEDURE (IRP) WHICH WILL REPLACE
EUROPEAN COMMISSION DECISION RECOGNITION PROCEDURE (ECDRP) FROM
JANUARY 1, 2024

Source text for Eikon:  ID:nGNErjJH2 
Further company coverage:  PHAR.AS 

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