Posted by Michael Wonder on 10 Oct 2024
Capricor Therapeutics announces initiation of rolling submission of biologics license application with US FDA for deramiocel for the treatment of Duchenne muscular dystrophy
9 October 2024 - Company plans to complete rolling BLA submission by end of 2024; application may be eligible for priority review by FDA.
Capricor Therapeutics announced today that it has initiated its rolling submission process with the US FDA for a biologics license application, seeking full approval for deramiocel to treat all patients diagnosed with Duchenne muscular dystrophy. cardiomyopathy.
