Brief: FDA Accepts Mesoblast’S Biologics License Application For Ryoncil®

Mesoblast

23/07/2024 13:42

July 23 (Reuters) - Mesoblast Ltd  MSB.AX :
    * FDA ACCEPTS MESOBLAST’S BIOLOGICS LICENSE APPLICATION
(BLA) FOR
RYONCIL® IN CHILDREN WITH STEROID-REFRACTORY ACUTE
GRAFT-VERSUS-HOST DISEASE (SR-AGVHD)
    * MESOBLAST LTD - MESOBLAST ANTICIPATES A DECISION ON OR
BEFORE
FDA'S PRESCRIPTION DRUG USER FEE ACT (PDUFA) GOAL DATE OF
JANUARY 7, 2025.

Source text for Eikon:  ID:nGNX4nYPnh 
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 ((Reuters.Briefs@thomsonreuters.com;))