May 6, 2025 – Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to givinostat for the treatment of patients with polycythemia vera (PV), a rare haematologic cancer, for which treatment options are limited.
“The FDA decision to grant givinostat Fast Track designation underscores the urgent need for innovative treatments for PV and highlights the potential of givinostat to make a meaningful difference,” said Paolo Bettica, MD, P