Something definitely has changed at FDA. Here is a recap of what has been announced just this quarter:
FDA Grants Rare Pediatric Disease Designation for Revascor
FDA Grants Orphan Drug Designation for Revascor
FDA Supports Accelerated Approval Pathway for Heart Failure
FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-142
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