Israel & European Union — European Medicines Agency

Israel: Imlifidase is approved in Israel, further expanding its international market reach.

European Union — European Medicines Agency: The European Union — European Medicines Agency conditionally approved Imlifidase and requested the PAES study, which has now been successfully completed, paving the way for a full marketing authorization application.

Israel: Israel is another market where Idefirix is approved, contributing to the product's international availability.

European Union — European Medicines Agency: The EMA's prior conditional approval and PRIME designation support Idefirix's regulatory standing in Europe, though not directly impacted by this event.

European Union — European Medicines Agency: The European Union — European Medicines Agency reviewed IDEFIRIX as part of its PRIority Medicines program, supporting its conditional marketing approval in Europe.