FDA ends review of Novartis data integrity inquiry

March 31, 2020

The U.S. Food and Drug Administration have announced it will not sanction Novartis over alleged data manipulation involving the drugmaker’s gene therapy Zolgensma. Back in August 2019, the FDA announced that early Zolgensma testing was manipulated. However, the organization left the treatment on the market.

After the FDA's inquiry, Novartis updated policies meant to speed data integrity disclosures.

Zolgensma is a $2.1 million-per-patient gene therapy for spinal muscular atrophy.

Read the Reuters report