FX.co ★ FDA Indicates Adequate Data For Mesoblast's Remestemcel-L BLA Submission In Children With SR-aGVHD

Mesoblast Limited, a company traded as MESO and MSB.AX, has disclosed that the U.S. Food and Drug Administration (FDA) signaled that the clinical data from the Phase 3 study MSB-GVHD001 appears adequate to underpin the submission of the proposed Biologics License Application (BLA). The application is for Remestemcel-L, a treatment for pediatric patients suffering from steroid-refractory acute graft-versus-host disease (SR-aGVHD).

Mesoblast plans to resubmit the application in the coming quarter, aiming to address any remaining issues related to product characterization. For more health-related news, visit rttnews.com.