Italfarmaco closes on EU okay for Duchenne drug

Capricor Therapeutics forges ahead with FDA on Duchenne drug, despite political tumult

The handling of the cell therapy is seen as a test case of both agency's resilience and regulatory flexibility.

Italfarmaco closes on EU okay for Duchenne drug

Italfarmaco's oral HDAC inhibitor Duvyzat has been recommended for approval in the EU as a treatment for Duchenne muscular dystrophy (DMD).

Duvyzat recommended for EU approval as DMD treatment

The Committee for Medicinal Products for Human Use, an arm of the European Medicines Agency known as CHMP for short, has recommended the approval of Duvyzat (givinostat) as a treatment for people with Duchenne muscular dystrophy (DMD), ages 6 and older, who are able to walk. The European Commission will review this recommendation, with a decision expected in July. CHMP’s recommendations are not binding, but are usually followed. If the DMD treat…

CHMP Recommends EU Approval for Duvyzat to Treat Duchenne Muscular Dystrophy

Italfarmaco S.p.A. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a conditional marketing authorization for Duvyzat®, a novel histone deacetylase inhibitor. The authorization is for the treatment of patients with Duchenne muscular dystrophy aged six years and older who are able to walk, when taken together with corticoster…

University of Florida Sigma Fraternities Fire Up Support for Duchenne Families - Jett Foundation

On April 11, 2025, the University of Florida campus came alive with the aroma of BBQ and the incredible energy of community giving. Hosted by the Sigma Phi Epsilon, Sigma Chi, and Delta Zeta fraternities/sorority, the second annual Sigma BBQ was a huge success, raising over $8,000 (and counting!) in support of families impacted by Duchenne muscular dystrophy. With a few more gifts still trickling in, the event has already surpassed last year’s f…