FibroGen, Inc. (FGEN) announced that the Office of Orphan Products Development of the FDA has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes. The company said Roxadustat showed an improvement in transfusion-independence in a subset of patients with high transfusion burden in a post-hoc analysis from the Phase 3 MATTHERHORN trial. The company is finalizing the Phase 3 protocol in the patient population for submission to the FDA in the fourth quarter of 2025.
Roxadustat is approved in Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis and not on dialysis.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.