FDA grants accelerated approval to first drug for Duchenne muscular dystrophy
Click here for the press release.
FDA´s DMD Draft Guidance
The FDA issued a guidance document. Here you will find the links to the materials for FDA’s DMD Draft Guidance:…
Video of the exon skipping workshop at the EMA, Wednesday April 29th 2015
Please click here to watch the video of the workshop on Antisense oligonucleotide-mediated exon skipping therapy development for Duchenne muscular dystrophy…
EMA Guideline on the quality, non-clinical and clinical aspects 4 of gene therapy medicinal products
Please click here for the European Medicines Agency guideline.
EMA recommends first-in-class medicine for treatment of Duchenne muscular dystrophy
Click here for the European Medicines Agency recommendation.
