The move follows encouraging Phase I data and a series of regulatory wins from the U.S. Food and Drug Administration
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
UK Prime Minister Keir Starmer praised the initiative, saying: “Unlocking opportunities for British businesses across the globe and delivering for working people back home is always the driving force behind my international engagements."
The approval expands the drug’s existing COPD indication, making it the only single-inhaler triple therapy (SITT) available for both respiratory conditions in China
This marks the second indication for which gumokimab has gained NDA review acceptance
The injectable borofalan (10B), developed by CNNC Headway—a subsidiary of China Isotope & Radiation Corporation (CIRC) under the China National Nuclear Corporation (CNNC)—has officially entered Phase I clinical trials
Myqorzo, a selective small-molecule cardiac myosin inhibitor, is designed to improve functional capacity and relieve symptoms in oHCM
CARsgen is working to transform outcomes for patients with solid tumors by advancing the potential of CAR T technologies
The approval is backed by data showing deep, durable responses and manageable tolerability
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