29 November 2023 - Italfarmaco Group announced today that the US FDA has extended the review process of the n ew drug application for givinostat, the company’s proprietary histone deacetylase inhibitor for the treatment of Duchenne muscular dystrophy. 

The new target action date for a decision under the Prescription Drug User Fee Act is now set for 21 March 2024.

Read Italfarmaco press release