The U.S. FDA granted Orphan Drug Designation to ANA-conjugated dactinomycin nanoemulsion for the treatment of Ewing’s sarcoma. ANA-conjugated dactinomycin nanoemulsion is developed by and in the pipeline of NanoSmart Pharmaceuticals, a biotech company based in Laguna Hills, CA. It is composed of liposome nano-capsules harboring anti-cancer antibiotics dactinomycin. The surface of the dactinomycin-containing liposome (nanoemulsion) is coated with NanoSmart’s human-sourced antinuclear antibody (ANA), which is responsible for targeting nanoemulsion to necrosis found in solid tumors thus achieving tumor-specificity for the nanoemulsion. Ewing’s sarcoma is a rare pediatric cancer of the bone with poor long-term prognosis. Treatment options include multidrug chemotherapy coupled with surgery and/or radiation. ANA-conjugated dactinomycin nanoemulsion could potentially achieve anti-tumor specificity while reducing toxicity to patients.