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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Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.
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.
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.