European Union — European Medicines Agency & United States

European Union — European Medicines Agency: The European Union — European Medicines Agency accepted the Marketing Authorization Application for Cevira, leading to milestone payments for Photocure.

United States: Photocure expanded its blue-light cystoscopy use in the United States and anticipates a larger commercial opportunity due to FDA reclassification.

European Union — European Medicines Agency: A marketing application for BeOne Medicines' Next-Generation BCL-2 Inhibitor has been submitted to the European Union — European Medicines Agency, and it sets manufacturing standards for BeOne Medicines' Suzhou facility.

United States: The United States hosts one of BeOne Medicines' production sites in New Jersey, serving as a North America biologics hub.

European Union — European Medicines Agency: The European Union — European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent for chronic spontaneous urticaria (CSU) in the European Union.