FibroGen: FDA Grants Orphan Drug Designation To Roxadustat For MDS
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FibroGen, Inc. announced that the FDA granted Orphan Drug Designation to roxadustat for treating myelodysplastic syndromes. Roxadustat showed improved transfusion-independence in patients with high transfusion burden in a Phase 3 trial. The company plans to submit the Phase 3 protocol to the FDA by Q4 2025. Roxadustat is already approved for anemia treatment in Europe, Japan, and other countries.
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