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.
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The sponsors of two monoclonal antibody products, tislelizumab and tremelimumab, are each seeking marketing approval for more than one indication.
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.
Incyte’s next-generation PI3K-delta inhibitor, parsaclisib, and Nobelpharma’s topical sirolimus gel are among the latest marketing authorization applications that have been filed in the EU.