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# Mesoblast Gets FDA OK for Rolling BLA
- URL: https://www.fdaweb.com/mesoblast-gets-fda-ok-for-rolling-bla/
- Published: 2019-04-16T12:00:00.000Z
- Updated: 2026-09-15T01:20:35.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5143878

FDA has agreed that Mesoblast can submit on a rolling basis a BLA for its allogeneic cellular medicine remestemcel-L for use in children with steroid-refractory acute Graft Versus Host Disease (SR-aGVHD). Mesoblast says it will submit each BLA module on a rolling basis as it is completed. The first module will be submitted shortly. The company previously received a fast track designation from the FDA for remestemcel-L in SR-aGVHD and is eligible for priority review once the BLA filing is completed and accepted by the agency. SR-aGVHD is a life-threatening complication of a bone marrow transplant in patients primarily being treated for blood cancers.