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TMB-003 Therapy to Reduce Scarring Wins FDA Orphan Drug Designation. Scleroderma treatment TMB-003 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA). Scleroderma News, 01/14/2021. (Also see Clinical Trials) This item was posted in the ISN Newsroom. Please check the newsroom daily for updates on scleroderma and other related articles.