When Novartis acquired their AveXis subsidiary in May 2018, they voluntarily self-disclosed to the FDA, and subsequently other health authorities, that some data previously submitted to the agency as part of the Zolgensma filing were inaccurate. Zolgensma was approved in the US for the treatment of type 1 spinal muscular atrophy, but on 6 August the FDA released a statement highlighting an investigation into data manipulation and whether the Swiss manufacturer should face civil or criminal penalties. This timely Scrip story looks at the claims about animal trials, the company’s s response and how the FDA’s position on whether Zolgensma should stay on the market.