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BioWorld - Sunday, May 11, 2025
Home » Keywords » remestemcel-L

Items Tagged with 'remestemcel-L'

ARTICLES

Ryoncil

Mesoblast prices pediatric stem cell treatment at $1.55 million

March 4, 2025
By Tamra Sami
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
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Ryoncil

Mesoblast prices pediatric stem cell treatment at $1.55 million

Feb. 27, 2025
By Tamra Sami
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
Read More
3D illustration of mesenchymal stem cells

Mesoblast scores first US nod for mesenchymal stromal cell therapy

Dec. 24, 2024
By Tamra Sami
Regenerative medicine company Mesoblast Ltd. received an early Christmas present from the FDA for approval of its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), for steroid-refractory acute graft-vs.-host disease (SR-aGvHD) in children 2 months and older, including adolescents.
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3D illustration of mesenchymal stem cells

Mesoblast scores first US nod for mesenchymal stromal cell therapy

Dec. 19, 2024
By Tamra Sami
Regenerative medicine company Mesoblast Ltd. received an early Christmas present from the FDA for approval of its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), for steroid-refractory acute graft-vs.-host disease (SR-aGvHD) in children 2 months and older, including adolescents.
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Mesoblast rockets on FDA’s acceptance of trial data for GVHD BLA

March 26, 2024
By Tamra Sami
Regenerative medicine company Mesoblast Ltd. saw its stock shoot up 45% on the news that the U.S. FDA is satisfied with the additional data submitted from the company’s phase III study for remestemcel-L for treatment of adults with steroid-refractory acute graft-vs.-host disease (SR-aGVHD) to support filing a BLA in pediatric patients with SR-aGVHD.
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Doctor with stethoscope listening to heart of girl

FDA offers life support to Mesoblast’s Revascor via rare pediatric disease designation

Jan. 23, 2024
By Tamra Sami
The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition.
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Doctor with stethoscope listening to heart of girl

FDA offers life support to Mesoblast’s Revascor via rare pediatric disease designation

Jan. 22, 2024
By Tamra Sami
The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition.
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Australian coins and bills

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

Dec. 5, 2023
By Tamra Sami
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.
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Australian coins and bills

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

Dec. 4, 2023
By Tamra Sami
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.
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Stem cells

Mesoblast’s hopes dashed again with second FDA complete response letter for remestemcel-L

Aug. 8, 2023
By Tamra Sami
Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
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More Articles Tagged with 'remestemcel-L'

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