Chinook Therapeutics announced that their drug, atrasentan, has been granted orphan drug designation by the European Commission for the treatment of primary IgA nephropathy (IgAN). The chronic kidney disease (CKD), IgAN, is the most common primary glomerular disease...
The European Commission announced that 70% of adults in the European Union (EU) are fully vaccinated against COVID-19, meeting the target that was initially set in January 2021, at the start of the vaccine rollout. This milestone marks a success for the EU’s...
The Medical Device Coordination Group (MDCG), part of the European Commission, has provided a guidance document navigating the use of codes under the In Vitro Diagnostic Regulation (IVDR). The codes are used to describe the qualifications of both the notified body...
The European Commission released a roadmap for its planned revision of pharmaceutical legislation for next year. With the adoption of the new strategy, which is “intended to make the European pharmaceutical system patient-centered, future-proof and...
The European Commission (EC) announced this week that it will now be accepting remote audits during the pandemic for some European medical device and in vitro companies. The cleared pathway comes in time for upcoming deadlines in May 2021 and 2022 for the EU’s MDR...
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