New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
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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.
Companies have the opportunity to tell the European Commission what they think about its proposed regulation that would overhaul the rules governing the use of substances of human origin.
Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.