Duchenne News Tags: Italfarmaco

October 27, 2025

Italfarmaco Addresses Patient Deaths and DUVYZAT® Safety in Community Letter

On October 24, 2025, Italfarmaco issued a statement addressing recent online discussions about patient deaths among individuals with Duchenne muscular dystrophy treated with DUVYZAT® (givinostat). The company stated that, based...

March 22, 2024

FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy

Jett Foundation is thrilled to share that the U.S. Food and Drug Administration (FDA) has approved Duvyzat (givinostat) to treat children and adolescents with Duchenne muscular dystrophy (DMD). Please read...

November 29, 2023

Italfarmaco Group Announces New PDUFA Date for Givinostat DMD NDA

Italfarmaco announces FDA extended the review process of the New Drug Application for Givinostat.

July 5, 2023

Italfarmaco Group Completes FDA Submission of New Drug Application for Givinostat in Duchenne and Receives Priority Review

Italfarmaco announces that the FDA has completed filing review and accepted the company’s NDA for Givinostat.

June 27, 2022

Italfarmaco Group Announces Positive Topline Data from Phase 3 Trial Showing Beneficial Effect of Givinostat in Patients with Duchenne Muscular Dystrophy

On Saturday, June 25, 2022, Italfarmaco Group shared a press release regarding positive topline data from its completed Phase 3 EPIDYS trial with Givinostat.

Programs

Events