The U.S. Food and Drug Administration said on Tuesday that some data from early testing of Novartis' more than $2 million gene therapy Zolgensma was manipulated, but the agency believes the treatment should remain on the market.
The FDA said it is carefully assessing the situation.
The FDA does not believe that the manipulation impacts the safety or testing surrounding the version of the drug, which treats spinal muscular atrophy (SMA), the leading genetic cause of death in infants.