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Ascentage Pharma Gets NDA Approval for Bcl-2 Inhibitor Lisaftoclax
This NDA is based on results from a pivotal registrational Phase II study in China (APG2575CC201) that evaluated the efficacy and safety of lisaftoclax in patients with r/r CLL/SLL.
Center For Drug Evaluation | 18/11/2024 | By Aishwarya
Mabwell Gets CDE Approval to Initiate Phase III Clinical Trial of 9MW2821
9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell, and it is the first of its kind in China to initiate clinical trials on the same target, with more than 400 subjects enrolled in the clinical studies for multiple indications.
Center For Drug Evaluation | 27/08/2024 | By Aishwarya
WestGene Secures Dual IND Approvals for EB Virus-Related mRNA Therapeutic Cancer Vaccine
WestGene Biopharma has announced that its mRNA therapeutic cancer vaccine, WGc-043, has received dual IND approvals from China's National Medical Products Administration (NMPA) and the US FDA.
Center For Drug Evaluation | 09/08/2024 | By Aishwarya
AusperBio Gets BTD for AHB-137 in Chronic Hepatitis B Treatment
AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. have announced that their investigational drug AHB-137 has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.
Center For Drug Evaluation | 11/07/2024 | By Aishwarya
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