New EU Filings
Executive Summary
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.
You may also be interested in...
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.
New EU Filings Include Tibsovo Resubmission, Pegunigalsidase & Daprodustat
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.
Parsaclisib & Sirolimus Gel Filed In EU For Rare Diseases
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.