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May 06, 2025 05:00 ET | Source: Italfarmaco

Italfarmaco Announces U.S. FDA Grants Fast Track Designation to Givinostat in Treatment of Polycythemia Vera

MILAN, Italy, 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...
April 25, 2025 10:17 ET | Source: Italfarmaco

CHMP recommends EU approval for Duvyzat to treat Duchenne muscular dystrophy

Recommendation is based on Phase 3 EPIDYS trial data that demonstrated Duvyzat (givinostat) provides statistically and clinically meaningful treatment benefits in individuals with Duchenne muscular...