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Europe Drug Review Approvals

New EU Filings Include Tibsovo Resubmission, Pegunigalsidase & Daprodustat

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Executive Summary

Servier is trying again with Tibsovo in the EU, while Protalix is using June 2021 data to support its filing for pegunigalsidase, which the US regulator turned down last April.

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New EU Filings

Adagrasib, Mirati Therapeutics' treatment for patients with non-small cell lung cancer, is among the latest new medicines that have been submitted for review for potential pan-EU approval.

New EU Filings

Tislelizumab, Novartis/BeiGene’s drug for treating esophageal and non-small cell lung cancer, is among the latest new medicines that have been submitted for review for potential pan-EU approval.

Tislelizumab & Tremelimumab Among Latest Filings In EU

The sponsors of two monoclonal antibody products, tislelizumab and tremelimumab, are each seeking marketing approval for more than one indication.

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