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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Business News
December 26, 2025 08:42 ET Third quarter economic growth data from some major economies including the U.S. were the main news in this holiday shortened week. GDP growth and industrial production data from the U.S. helped to boost morale, while the consumer confidence survey results were less upbeat. In Europe, the quarterly economic growth data from the U.K. drew attention, while the minutes of the Australian central bank’s latest policy session was in focus in Asia.