The decision clears the drug as a monotherapy for adults with unresectable, locally advanced or metastatic non-small cell lung cancer
The approval has been secured in partnership with Yabao Pharmaceuticals, a major player in China’s paediatric medicine segment
Successful inspection outcome strengthens company’s regulatory compliance and manufacturing standards in China
As per GlobalData, CARsgen’s satri-cel could mark a major breakthrough in solid tumor treatment as competition intensifies
The decision is based on the phase 3 DESTINY-Breast11 trial
Desidustat tablets are a novel oral HIF-PHI approved for treating anaemia in non-dialysis adult CKD patients
Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival
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
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
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