REGULATORY

Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report

April 16, 2020
The Pharmaceuticals and Medical Devices Agency (PMDA) on April 14 published its review report for Novartis Pharma’s Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy (SMA) approved in March. The report blames the company for the long delay…

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