givinostat

ITF Therapeutics Shares Update on DUVYZAT™ Following FDA Approval

Following the FDA’s approval of DUVYZAT™ (givinostat) on March 21, 2024, ITF Therapeutics, LLC, the company responsible for producing and marketing DUVYZAT™ in the United States, today shared an update on the drug and related…

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FDA Grants Approval to DUVYZAT™ (Givinostat)

PPMD is excited to learn that the FDA has granted approval to DUVYZAT™ (givinostat), a histone deacetylase (HDAC) inhibitor indicated for individuals diagnosed with Duchenne muscular dystrophy from six years of age and older. DUVYZAT™…

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Italfarmaco Shares Updates Ahead of Givinostat PDUFA Date

Italfarmaco S.p.A. has announced that the full results from the pivotal phase 3 EPIDYS clinical trial of givinostat in ambulant Duchenne patients six years of age and older have been published in The Lancet Neurology….

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November 29, 2023

Italfarmaco Announces PDUFA Extension for the FDA’s Review of Givinostat

Italfarmaco Group announced an extension in the FDA’s review of the New Drug Application (NDA) for Givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor for the potential treatment of Duchenne. The new Prescription Drug User…

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Italfarmaco Group Announces NDA Accepted for Givinostat

PPMD is excited to learn that the FDA completed its filing review and accepted Italfarmaco Group’s New Drug Application (NDA) for Givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor for the treatment of individuals with…

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Italfarmaco Announces Positive Topline Data from Phase 3 Trial Showing Beneficial Effect of Givinostat in Duchenne

Italfarmaco’s Chief Medical Officer, Dr. Paolo Bettica presented a Late-Breaking News session today at PPMD’s 2022 Annual Conference, announcing positive topline data from its completed Phase 3 EPIDYS trial with Givinostat in boys with Duchenne….

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October 27, 2021

Calling All Individuals with Becker Muscular Dystrophy – We Need You!

Do you or a loved one have a diagnosis of Becker muscular dystrophy? If so, please read these important updates which are focused on how we can help individuals with Becker and their families. Becker…

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Recently Reported Updates from PPMD’s 2021 Virtual Annual Conference

PPMD’s 2021 Virtual Annual Conference: Recently Reported Updates As a new addition to PPMD’s 2021 Virtual Conference, PPMD invited industry partners to share new data with the community live during the Conference in a series…

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Italfarmaco Announces Topline Data from Phase 2 Trial with Givinostat in Patients with Becker

This afternoon at PPMD’s Virtual Annual Conference, Italfarmaco shared Phase II Study results from the Givinostat trial in patients with Becker. They also issued a press release below. Although they did not meet the primary…

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October 12, 2020

Italfarmaco Receives FDA Rare Pediatric Disease Designation & Completes EPIDYS Phase 3 Trial Enrollment

Italfarmaco has provided an update on the development of Givinostat, sharing that the FDA has granted a Rare Pediatric Disease designation to Givinostat for the treatment of Duchenne, which allows an expedited review process for…

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