The Phase III, double-blind, placebo-controlled DELOS study randomized 65 Duchenne Muscular Dystrophy patients who were 10-18 years of age and...
Santhera Pharmaceuticals is pleased to note the launch of Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in the United States by Catalyst Pharmaceuticals, Inc. the Company’s commercialization partner for North America
Italfarmaco S.p.A. announced that the FDA has approved Duvyzat (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD), a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood.
The European Medicines Agency has granted under a special exemption known as a conditional marketing authorization, approval for Translarna (ataluren)...
Santhera Pharmaceuticals and ReveraGen announce that JAMA Neurology has published positive results of the 24-week primary efficacy and safety analysis from the VISION-DMD study evaluating vamorolone, an investigational drug for the treatment Duchenne muscular dystrophy (DMD)
Santhera Pharmaceuticals announces that the FDA has approved Agamree (vamorolone) oral suspension 40 mg/ml for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
Prosensa provides subset analyses on outcomes from drisapersen its investigational antisense oligonucleotide, for Duchenne Muscular Dystrophy boys seven years or...
Santhera Pharmaceuticals and ReveraGen BioPharma, Inc announce the successful completion of the mid-cycle review meeting by the FDA of the new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD)
Santhera Pharmaceuticals announces that Agamree (vamorolone) has been approved in the European Union (EU) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, independent of the underlying mutation and ambulatory status
Sarepta Therapeutics has announced that the FDA Peripheral and Central Nervous System Advisory Committee (PCNSC) met to review the new...