Breakthrough Therapy designation complements Rusfertide’s Orphan Drug and Fast Track designations, which together confer multiple benefits to the development program U.S. New Drug Application filing ...
Rusfertide effectively maintained hematocrit control below 45% and reduced phlebotomy eligibility in PV patients through 52 weeks. Patients switching from placebo to rusfertide achieved rapid and ...
Rusfertide has received orphan drug, fast track, and breakthrough therapy designations from the FDA, and in this interview, Andrew Kuykendall, MD, Moffitt Cancer Center, emphasizes the critical need ...
Breakthrough designation for rusfertide was supported by positive 32-week data from the Phase 3 VERIFY study, which was presented as a late breaking abstract highlighting its practice-changing ...