Novartis said AveXis could face a civil or criminal penalty after the US FDA said the Swiss firm manipulated preclinical data for spinal muscular replacement gene therapy trials . It was allegedly aware data from in vivo mouse studies had been manipulated on 14 March , but waited until more than a year after Zolgensma had been approved to notify the FDA , according to a memo . The Administration said the overall data supported the drug remaining on the market .
Novartis subsidiary AveXis could face a civil or criminal penalty after the US FDA said the Swiss firm manipulated preclinical data for spinal muscular atrophy gene therapy Zolgensma. AveXis was allegedly aware data from in vivo mouse studies had been manipulated on 14 March, but waited until more than a month after Zolgensma had been approved to notify the FDA, according to a memo. The Administration said the overall data supported the treatment remaining on the market.