Posted by Michael Wonder on 07 Jan 2025
Restem receives FDA fast track designation for Restem-L for idiopathic inflammatory myopathy
7 January 2025 - Second regulatory designation for Restem-L, a lead ULSC program, following the recent orphan drug designation.
RESTEM today announced that the US FDA has granted fast track designation for Restem-L, the Company’s umbilical cord outer lining stem cells program for the treatment of polymyositis and dermatomyositis, a rare auto-immune disease, now defined by the FDA as idiopathic inflammatory myopathy.
