Reported Earlier, Mesoblast Resubmits Biologics License Application (BLA) For Ryoncil To FDA, Targeting Treatment For Children With SR-aGVHD
Reported Earlier, Mesoblast Resubmits Biologics License Application (BLA) For Ryoncil To FDA, Targeting Treatment For Children With SR-aGVHD
早前報道，mesoblast已向FDA重新提交了Ryoncil的生物製品許可申請（BLA），旨在治療SR-aGVHD兒童。
FDA granted remestemcel-L Fast Track designation, a process to facilitate the development and expedited review of therapies for serious conditions that fill unmet medical needs, and Priority Review designation, which is given to drugs that treat a serious condition and provide a significant improvement in safety or effectiveness over existing treatments.
FDA授予remestemcel-L 快速通道設計，以便促進治療嚴重疾病且填補未滿足醫療需求的藥物開發和加快審查，並授予優先審查資格，該資格頒發給治療嚴重疾病並比現有治療提供顯著安全或有效改進的藥物。
The BLA resubmission upon acceptance is expected to have a review period of between two and six months from receipt.
接受後BLA重新提交的審查期望爲2至6個月。
譯文內容由第三人軟體翻譯。
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