Kygevvi treats a disease so rare that comprehensive clinical evidence could not realistically be collected. OncoAct turns the entire genome of a solid tumour into information that can guide treatment. One is a medicine, the other a diagnostic platform, and they reach European patients through different regulatory systems. Together, they show where part of Europe’s health technology pipeline is heading.
Between 15 March and 15 September 2026, the European Union granted 41 new centralised marketing authorisations for medicines. Counted by where the company behind them is headquartered, and treating Europe as the continent, the EU and EEA plus the United Kingdom and Switzerland, 22 were associated with European companies and 19 with companies headquartered elsewhere. Eleven of the European authorisations contained a new active substance.
Medical devices do not pass through the same centralised authorisation procedure. Manufacturers obtain CE marking after demonstrating compliance with the Medical Devices Regulation or the In Vitro Diagnostic Medical Devices Regulation. Higher-risk products are assessed by independent notified bodies.