Kids News

Today, Capricor Therapeutics formally announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s amendment to the Biologics License Application (BLA) for Deramiocel, and the FDA will be extending the current Prescription… The post Update on Deramiocel: PDUFA Date Extended appeared first on Parent Project Muscular Dystrophy.

Precision BioSciences, Inc. today announced the dosing of the first patient in the Phase 1/2 FUNCTION-DMD clinical trial, evaluating the safety, tolerability, and efficacy of PBGENE-DMD for the treatment of Duchenne. PBGENE-DMD is Precision’s investigational… The post Precision Biosciences Doses First Patient in FUNCTION-DMD Trial of PBGENE-DMD appeared first on Parent Project Muscular Dystrophy.

As we approach August 22, the FDA’s current Prescription Drug User Fee Act (PDUFA) action date for Capricor Therapeutics’ Biologics License Application (BLA) for Deramiocel, PPMD recognizes how closely the Duchenne community is watching for… The post Deramiocel: Where We Are Today appeared first on Parent Project Muscular Dystrophy.

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 post Update on the FDA’s Review of Deramiocel: Continuing the Path Forward appeared first on Parent Project Muscular Dystrophy.

Today, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) met to discuss Capricor Therapeutics’ Biologics License Application (BLA) for Deramiocel as a potential treatment for Duchenne muscular dystrophy (Duchenne). Following a full day… The post Thank You for Raising Your Voices During the Deramiocel FDA Advisory Committee Meeting appeared first on Parent Project Muscular Dystrophy.