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Boehringer & BridgeBio Seek EU Fast-Track Status; Enfortumab Vedotin Reverts To Standard Review

 
• By Neena Brizmohun

Applications for the accelerated assessment of planned EU marketing applications for two drugs are being considered by the European Medicines Agency.

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An accelerated assessment can cut months off the EMA's drug review time • Source: Alamy

The European Medicines Agency is due to decide this week whether to fast track its review of the planned EU marketing applications for two products – spesolimab, from Boehringer Ingelheim, and BridgeBio Pharma’s fosdenopterin.

Meanwhile, Astellas Pharma/Seagen’s urothelial cancer drug, enfortumab vedotin, has lost the fast-track status it was

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