Osiris Therapeutics, Inc.

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 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

Some 10 years since Japan introduced policies, regulations and review pathways to encourage the development and commercialization of cell therapy products, the country has recently modified some regul

Some 10 years since Japan introduced policies, regulations and review pathways to encourage the development and commercialization of cell therapy products, the country has recently modified some regul