New Filings At The EMA
New medicines under evaluation at the European Medicines Agency. This article was updated on March 1.
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The European Medicines Agency will fast-track Shionogi’s new antibiotic, , through regulatory review when the company files for approval but there’s no special treatment for Roche’s new tissue agnostic oncologic, . More than half the accelerated assessment requests made in 2018 to the EMA failed to make the grade.
Four orphan drugs, Roche’s tissue agnostic cancer treatment entrectinib, and a single-dose oral vaccine for cholera are among the raft of new products that the European Medicines Agency has started to review for potential approval across the EU.
In contrast with the five COVID-19 vaccines that are approved in the EU under conditional marketing authorizations, the European Medicines Agency has recommended that Valneva’s vaccine receive a standard approval.