Posted by Michael Wonder on 05 Mar 2025
Capricor Therapeutics announces FDA acceptance and priority review of its biologics license application for deramiocel to treat Duchenne muscular dystrophy
4 March 2025 - FDA assigns PDUFA target action date of 31 August 2025.
Capricor Therapeutics today announced the US FDA has accepted for review its biologics license application seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy cardiomyopathy.
