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Europe Drug Review Regulation

Tislelizumab & Tremelimumab Among Latest Filings In EU

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Executive Summary

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

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New EU Filings

Pharming’s leniolisib for treating the rare immunodeficiency APDS is among the new drugs that the European Medicines Agency has started reviewing for potential EU marketing approval.

New EU Filings

Santhera Pharmaceuticals’ vamorolone for treating Duchenne muscular dystrophy is among the latest medicines that have been submitted for review for potential pan-EU approval.

New EU Filings

Fresenius Kabi’s tocilizumab biosimilar candidate is among the latest medicines that have been submitted for review for potential pan-EU approval.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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