Dystrophin Archives - PharmaLive

FDA Lifts Clinical Hold on Solid Biosciences’ DMD Gene Therapy Trial

Adeno-Associated Virus (AAV), Adverse Events, Business, Clinical Hold Lift, Clinical Trials, Duchenne Muscular Dystrophy (DMD), Dystrophin, FDA, FDA/Regulatory, Mutations, Premarket Trading, R&D, Shares

Shares of Solid Biosciences skyrocketed in trading after the company announced the U.S. Food and Drug Administration lifted the clinical hold on the IGNITE DMD Phase I/II clinical trial.

Option Care Health Selected as a Limited Distribution Provider of VILTEPSO

Business, Duchenne Muscular Dystrophy, Dystrophin, Exon 53 Skipping Therapy, Infusion Therapy, Neuromuscular Disorders, Therapeutics

Option Care Health Inc., the largest U.S. independent provider of home and alternate site infusion services, was selected to participate in the limited distribution network of VILTEPSO (viltolarsen) for patients with Duchenne Muscular Dystrophy who are amenable to exon 53 skipping therapy.

FDA Approves Viltepso for Duchenne Muscular Dystrophy

Accelerated Approval, Approvals, Duchenne Muscular Dystophy (DMD), Dystrophin, Exon 53 Skipping Therapy, FDA, FDA/Regulatory, Infusions, Muscle Wasting Disorders, Neurologists, Therapeutics

The U.S. Food and Drug Administration granted accelerated approval for NS Pharma’s Viltepso (viltolarsen) injection for patients with Duchenne muscular dystrophy who are amenable to exon 53 skipping therapy.