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FDA May Struggle To Keep Up With Uptick In Gene Therapy Applications

By David Roza
June 7, 2019 at 4:10 PM
Lawyers in the gene therapy field said FDA’s approval of AveXis’ Zolgensma, a new drug for treating spinal muscular atrophy (SMA), lays the groundwork for an expected wave of future gene therapy drug applications. But they say FDA may struggle to keep pace, especially when it comes to hiring enough reviewers, and note continued questions surrounding the durability of gene therapy treatment effects and how manufacturing technologies will be built to scale. Zolgensma, which received FDA approval May 24, has...


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