Mesoblast Limited

Mesoblast ’s graft-versus-host disease treatment Ryoncil (remestemcel-L-rknd) exemplifies how shortfalls in product characterization and potency assay development can lead to lengthy delays in approva

The clinical development of Mesoblast ’s Ryoncil (remestemcel-L-rknd) stretched more than 25 years from investigational new drug application submission to US Food and Drug Administration approval for

The US Food and Drug Administration’s review of Mesoblast ’s Ryoncil (remestemcel-L-rknd) shows the agency can change its mind about the quantum of clinical data for a rare disease therapeutic applic

Equillium is hoping that unmet medical need and long-term efficacy will persuade the US Food and Drug Administration to approve itolizumab for acute graft-versus-host disease (aGVHD) despite its Phase