The European Commission, the United States Food and Drug Administration and the European Medicines Agency have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information
GlaxoSmithKline (GSK) and ViiV Healthcare, the global specialist HIV company majority-owned by GSK yesterday announced regulatory submissions to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)
Gedeon Richter Plc announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the company's application for cariprazine
The European Medicines Agency (EMA) published 2016 annual report. It focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innova...