Brief: Xbrane Updates On Ranibizumab Biosimilar Candidate FDA Filing

Xbrane Biopharma AB

15/12/2022 07:10

Dec 15 (Reuters) - Xbrane Biopharma AB  XBRANE.ST :
    * XBRANE PROVIDES AN UPDATE ON RANIBIZUMAB BIOSIMILAR
CANDIDATE
FDA FILING
    * DELIVERY OF A CRITICAL REPORT REQUIRED FOR RE-SUBMISSION
HAS
BEEN DELAYED AND THEREFORE RE-SUBMISSION OF BLA HAS BEEN
POSTPONED TO Q1 OF 2023
    * XBRANE WILL NEXT UPDATE ON BLA UPON SUCCESSFUL VALIDATION
BY
FDA, WHICH IS EXPECTED 60 DAYS POST RE-SUBMISSION

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