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.
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.
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.
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 ADRs Rise 22%, FDA Approves Ryoncil for Pediatric Patients -- Update
The American depositary receipts of Mesoblast were trading higher after hours Wednesday following news the Food and Drug Administration approved its Ryoncil as a treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.
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,
Mesoblast’s RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stromal Cell (MSC) Therapy
RYONCIL (remestemcel-L) is the first MSC product approved by FDA for any indication.RYONCIL is the first FDA-approved therapy for children aged 2
Mesoblast Finally Gets Its Approval In GVHD: Where Now?
Investment risks and competition challenge Mesoblast Limited's recent approval for Remestemcel-L in treating ...
Teva, Sanofi say bowel disease drug met primary targets
Israel's Teva Pharmaceutical Industries and French drugmaker Sanofi said a study of a drug to treat ulcerative colitis and ...
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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 ...
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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 ...