Brief: Guerbet Says EMA, FDA Agree To Review Gadopiclenol Marketing Authorisation

Guerbet SA

29/03/2022 17:20

March 29 (Reuters) - Guerbet SA  GRBT.PA :
    * EMA AND FDA AGREE TO EVALUATE THE MARKETING AUTHORISATION
APPLICATION DOSSIERS FOR GADOPICLENOL
    * THE FDA HAS ACCEPTED THE REQUEST FOR PRIORITY REVIEW,
WHICH
COMMITS IT TO RULE ON THE FILE BY SEPTEMBER 21, 2022
    * FILES ARE SUPPORTED BY DATA FROM TWO PHASE III STUDIES OF 
GADOPICLENOL

Source text for Eikon:  ID:nGNE9bcV0F 
Further company coverage:  GRBT.PA 

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