4 August 2023 - Mesoblast Limited today announced that the US FDA has provided a complete response to its biologics license application resubmission for remestemcel-L for the treatment of paediatric steroid-refractory acute graft versus host disease and requires more data to support marketing approval. 

To obtain the data required, Mesoblast will conduct a targeted, controlled study in the highest-risk adults with the greatest mortality.

Read Mesoblast press release