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Latest From Review Pathway
In 2018, the European Medicines Agency considered 24 requests from drug companies for fast-track review of their planned marketing authorization applications. The agency has granted at least nine requests, eleven have been rejected and the results of four have yet to be disclosed.
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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