Pharmaceuticals, Biotechnology and Life Sciences
The U.S. Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’s Durham, N.C. site, a multi-product gene therapy manufacturing facility.
Novartis has announced new data that reinforce the transformational benefit of Zolgensma (onasemnogene abeparvovec), an essential one-time treatment for spinal muscular atrophy (SMA).
Novartis’s Biologics License Application (BLA) for Zolgensma, designed to tackle the genetic root cause of spinal muscular atrophy (SMA) Type 1, a deadly neuromuscular disease, was accepted by the U.S. Food and Drug Administration (FDA).