-
Update on the FDA’s Review of Deramiocel: Continuing the Path Forward
Today, Capricor Therapeutics shared an important update on the FDA’s review of the Biologics License Application (BLA) for Deramiocel, the company’s cell therapy for the treatment of Duchenne muscular dystrophy-associated cardiomyopathy. Capricor has indicated that the company plans to submit an amendment to the FDA that will include additional data and analyses to support the…
-
US developer gearing up for first-in-human trial of Duchenne cell therapy
A U.S. biopharmaceutical company is gearing up to launch its first clinical trial of a novel cell therapy designed to restore lost muscle cells in people with Duchenne muscular dystrophy (DMD). Texas-based IPS Heart announced that it is preparing an investigational new drug application or IND — a formal request to the U.S. Food and Drug…








