Servier has resubmitted a marketing application to the European Medicines Agency for its cancer drug, Tibsovo (ivosidenib tablets), more than a year after a previous EU filing was withdrawn for the product, which is approved in the US for treating acute myeloid leukemia (AML) and cholangiocarcinoma.
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.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.