Brief: Mesoblast Receives Complete Response From U.S. FDA For Biologics License Application For Steroid-Refractory Acute Graft Versus Host Disease In Children

Mesoblast

04/08/2023 01:12

Aug 3 (Reuters) - Mesoblast Ltd  MSB.AX :
    * MESOBLAST RECEIVES COMPLETE RESPONSE FROM U.S. FOOD AND
DRUG
ADMINISTRATION FOR BIOLOGICS LICENSE APPLICATION FOR
STEROID-REFRACTORY ACUTE GRAFT VERSUS HOST DISEASE IN CHILDREN
    * MESOBLAST-HAS MET PRE-SPECIFIED PRIMARY ENDPOINT,
PROSPECTIVELY
AGREED WITH FDA, OF A SINGLE-ARM PHASE 3 TRIAL IN 54 CHILDREN
WITH SR-AGVHD

Source text for Eikon:  ID:nGNX469HHj 
Further company coverage:  MSB.AX 

 ((Reuters.Briefs@thomsonreuters.com;))