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
This achievement validates global demand and catapults Wanbury into high-growth acceleration
NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration
Fid?s brings core strengths across imaging applications and human biology, supporting work in digestive disease, GI oncology, and select solid tumors
The Phase III programme, Enith1 and Enith2, is expected to launch this quarter
The trials, which enrolled over 1,000 patients across 398 sites in 17 countries, showed that the drug was safe and well-tolerated—but ultimately failed to deliver the hoped-for clinical results
The early-stage trial demonstrated an excellent safety profile alongside clinically meaningful improvements in visual acuity
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
The EU approval of DAWNZERA is an important milestone that reflects our ongoing commitment to bring this innovative medicine to people in need across the globe
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