EU’s Innovative Drug Approval Tally Shows Sharp Decline

Just 36 Products With New Active Substances Got The All-Clear In 2023

The numbers may be down, but Europeans will in future be able to gain access to a number of highly innovative medicines, including several products for hard-to-treat cancers, a gene therapy for severe and moderately severe hemophilia B, and two vaccines against disease caused by respiratory syncytial virus.

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The European Commission is responsible for EU drug marketing authorizations • Source: Shutterstock

In 2023, the European Commission approved 36 medicines containing a new active substance, the lowest number since 2019 when just 28 NAS-containing drugs gained an EU-wide marketing authorization.

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