India, Nov. 7 -- In medicine, one truth transcends time: a drug's worth is measured not merely by how effectively it fights disease, but also by how safely it does so.
One medicine that has recently drawn the FDA's attention over emerging safety concerns is Novartis Inc.'s (NVS) Zolgensma gene therapy.
Approved in the U.S. in May 2019, Zolgensma is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA). Administered as a one-time intravenous infusion, Zolgensma carries a boxed warning for serious liver injury and acute liver failure, including reported fatal cases. Its prescribing information also highlights several other important s...