FDA hits Mesoblast with CRL, ask­ing for more adult da­ta in acute graft-ver­sus-host dis­ease

The FDA hand­ed a com­plete re­sponse let­ter to Mesoblast for its BLA sub­mis­sion of its drug for pe­di­atric steroid-re­frac­to­ry acute graft-ver­sus-host dis­ease (SR-aGVHD),

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