Gene Therapies: Accelerated Approval Open For Some, But Not All, Neurodegenerative Disease Treatments

US FDA’s Gottlieb tells J.P. Morgan that curative gene therapies may be ripe for accelerated approval while those targeting symptoms may require more conventional development programs; forthcoming agency guidance will articulate this divide specific to neurodegenerative diseases, he says.

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The US FDA will soon clarify the regulatory pathways and evidentiary requirements for gene therapies for neurodegenerative diseases based upon a treatment’s intended effect, Commissioner Scott Gottlieb said Jan. 8.

In a keynote address to the J.P

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