US. FDA updates PDUFA action date for lifileucel for the treatment of advanced melanoma

Iovance Biotherapeutics

14 September 2023 - FDA extends PDUFA date to 24 February 2024 on resource constraints and agrees to work with Iovance to expedite remaining review.

Iovance Biotherapeutics today announced the US FDA, because of resource constraints, requires additional time to complete the priority review of Iovance’s biologics license application for lifileucel.

Read Iovance Biotherapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Timelines , Dossier