US FDA approves Mesoblast's cell therapy for graft-versus-host disease
The U.S. Food and Drug Administration on Wednesday approved Mesoblast's cell therapy for treating a type of complication that occurs after a stem cell or bone marrow transplant called graft-versus-host disease (GVHD).
After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy
More than four years later—and after two rejections from the agency—Mesoblast has finally gained an endorsement from the U.S. regulator for its first approved drug.
FDA Approves Mesenchymal Stromal Cell Therapy for Refractory Acute GVHD in Kids
Reaching the end of a long road to approval, the first mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft-versus-host disease (GVHD) finally reached the FDA green light. The approval of remestemcel-L (Ryoncil) specifies use in pediatric patients 2 months or older with steroid-refractory acute GVHD.
Mesoblast's Cell Therapy Treatment For Graft Versus Host Disease Gets FDA Approval, Stock Surges
Mesoblast's Ryoncil is now FDA-approved for pediatric SR-aGvHD, marking a milestone in mesenchymal stromal cell therapies in the U.S.
MESO Stock Up as FDA Approves Ryoncil for Graft Versus Host Disease
Mesoblast Limited MESO announced that the FDA has approved Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in children aged two months and older,
Pluri Congratulates Mesoblast on FDA Approval of First Mesenchymal Stromal Cell Therapy for Steroid-Refractory Acute Graft-Versus-Host Disease
Silviu and the team at Mesoblast have opened a new chapter in harnessing MSC therapies to treat devastating conditions like SR-aGVHD. This approval validates the immense therapeutic promise of MSCs and inspires all of us working in this space to redouble our efforts to bring innovative solutions to patients in need.
Mesoblast Finally Gets Its Approval In GVHD: Where Now?
Investment risks and competition challenge Mesoblast Limited's recent approval for Remestemcel-L in treating ...
Medscape13d
High-Fiber Diet Linked to Improved Stem Cell Transplant, GvHD Outcomes
Although low-fiber diets are typically recommended during transplant, patients with higher-fiber diets show improved survival ...
Benzinga.com3d
What's Going On With Mesoblast Shares Thursday?
Mesoblast announces that the FDA approved Ryoncil. Ryoncil is the only approved therapy for steroid-refractory acute graft ...
MedPage Today12d
Benefits of Transplant for Pediatric Sickle Cell Disease Add Up a Decade Later
Transplant is beneficial earlier in life, Wang told MedPage Today, but carries potential short- and long-term side effects.
Business Insider3d
FDA Approves Mesoblast's Cell Therapy To Treat Steroid-refractory Acute Graft-versus-host Disease
These MSCs are isolated from the bone marrow of healthy adult human donors. Steroid-refractory acute graft-versus-host disease is a serious and life-threatening condition that can occur as a ...