FDA delays decision on Roche's SMA drug to review extra data

The FDA has extended its review of Roche’s spinal muscular atrophy (SMA) drug risdiplam after the pharma submitted additional data.

FDA lets off Novartis after gene therapy data row

Novartis is off the hook following the FDA’s review of data manipulation in the filing of its hugely expensive spinal muscular atrophy gene therapy Zolgensma.

Novartis closes on EU approval for SMA gene therapy Zolgensm...

Novartis publishes long-term data from SMA gene therapy

Novartis has produced data demonstrating its Zolgensma gene therapy produces long term benefits in the rare muscle wasting disease spinal muscular atrophy – information that will be closely

Novartis pulls rival to Roche’s risdiplam in SMA, says marke...

FDA cues up May verdict for Roche’s SMA challenger risdiplam