Tag Archive for: rare genetic disease

Egetis intends to submit a marketing authorisation application for Emcitate® to the European Medicines Agency based on existing clinical data

Egetis concludes, based on recent regulatory interactions, that available Triac Trial I data together with recently published long-term data are sufficient for a Marketing Authorisation Application in Europe Having all clinical data required for regulatory submission already at hand significantly reduces the remaining risk for Emcitate Revised submission timelines will be communicated as soon as […]