
08/12/2025
The FDA supported the advancement of roxadustat for the treatment of patients with anemia-associated lower-risk myelodysplastic syndrome, agreeing upon important design elements for a pivotal phase 3 trial for this patient population in a Type C meeting.
https://hubs.li/Q03CfZQt0
Roxadustat’s developers intend to file the full phase 3 protocol to the FDA in the fourth quarter of 2025.