BioMarin’s Roctavian & Argenx’s Efgartigimod Among Eight Hopefuls Awaiting EU Verdict
Will BioMarin be second time lucky with its hemophilia gene therapy Roctavian in the EU? The European Medicines Agency could soon decide whether the product should be approved.
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BioMarin’s Hemophilia Gene Therapy Among Nine Products On Track For EU-Wide Approval
Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.
Valneva Wins EU Nod For COVID-19 Vaccine
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.
Coronavirus Notebook: Adapted Comirnaty Vaccine Under EU Review, Sanofi & GSK Laud Next-Gen Booster
Valneva expects its vaccine candidate to be approved this month. Meanwhile, the core functions of the UK’s Vaccine Taskforce are to be transferred to the UK Health Security Agency and the Office for Life Sciences.