Author Archives: Jose Marques Lopes PhD

Suvodirsen Receives FDA’s Fast Track Status to Treat DMD

The U.S. Food and Drug Administration (FDA) has granted fast track designation to suvodirsen as a treatment for people with Duchenne muscular dystrophy (DMD). The agency’s decision — which will expedite the review process for suvodirsen — was based on experimental and preclinical data demonstrating the treatment’s…

European Agency OKs Marketing Authorization for Puldysa to Treat Respiratory Decline in Duchenne MD

The European Medicines Agency (EMA) has validated a marketing authorization application for Puldysa (idebenone) for treating respiratory dysfunction in Duchenne muscular dystrophy (DMD) patients who do not take glucocorticoids. This means that the submission, which was made as a conditional marketing authorization (potentially granted to therapies whose immediate benefit…