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Mesoblast raising AU$97M for registration trials in GVHD, chronic back pain - Vimarsana News

Mesoblast raising AU$97M for registration trials in GVHD, chronic back pain

Published: December 4, 2023

Regenerative medicine company Mesoblast Ltd. plans to raise AU$97 million (US$64.5 million) to conduct additional phase III registration trials for its allogeneic stem cell treatment for steroid-refractory acute graft-vs.-host disease and for chronic back pain, as required by the U.S. FDA.

Source: bioworld.com
Related Topics:
Mesoblast LtdMesoblast LtdAcute Graft Vs Host DiseaseRemestemcel LAllogeneic Stem Cell TreatmentSteroid Refractory Acute Graft Vs Host DiseaseChronic Back PainRexlemestrocel LHeart Failure
FDA Issues CRL to BLA Resubmission for Remestemcel-L in Pediatric Steroid-Refractory aGVHD - Vimarsana News

FDA Issues CRL to BLA Resubmission for Remestemcel-L in Pediatric Steroid-Refractory aGVHD

Published: August 4, 2023

The FDA has released a complete response letter to its biologics license application resubmission, indicating that it needs more data to support approval for remestemcel-L for the treatment of pediatric patients with steroid-refractory acute graft-vs-host disease.

Source: onclive.com
Related Topics:
United StatesSilviu ItescuInternational ConsortiumMarrow Transplant ResearchOncologic Drugs Advisory CommitteeInternational BloodDrugs Advisory CommitteeMount Sinai AcuteHematologic OncologyBiologics License ApplicationRemestemcel LAcute Graft Vs Host Disease