FDA sets back Novartis plans to expand use of SMA gene therapy

FDA sets back Novartis plans to expand use of SMA gene therapy

Source: 
BioPharma Dive
snippet: 

Novartis has to run a new clinical trial before it can seek U.S. approval for an experimental formulation of its spinal muscular atrophy gene therapy Zolgensma, the Swiss drugmaker said Wednesday, in the latest setback to its plans to treat older patients with the neuromuscular disease.