and Breakthrough Therapy Designations by both the US FDA and China’s NMPA for the treatment of patients with locally advanced or metastatic ROS1-positive NSCLC. Based on pooled results of the TRUST-I ...
In addition, in June 2024, IBI343 was granted Fast Track Designation by the US Food and Drug Administration (FDA) for the treatment of advanced ... including gastric cancer.” NMPA Breakthrough Therapy ...
Zhaoke Ophthalmology Limited is responsible for developing and obtaining regulatory approval for NVK-002 in Greater China, ...
Innovent & ASK Pharm Announce NMPA Approval Of Limertinib,3rd-Gen EGFR TKI For Lung Cancer Treatment
(RTTNews) - Innovent Biologics Inc. (IVBXF.OB) and Jiangsu Aosaikang Pharmaceutical Co. Ltd. or ASK Pharm announced that China's National Medical Products Administration (NMPA) has approved the ...
IceCure Medical has submitted a regulatory filing to China's National Medical Products Administration (NMPA) seeking the approval of its ProSense cryoablation system, which is designed for ...
A separate NDA for the first-line treatment in adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations is currently under NMPA review.
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