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Duchenne News Tags: Italfarmaco

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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...
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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.
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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.
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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.
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