Last edition
News about "Center for Drug Evaluation (CDE)"
FDA Grants Priority Review to Sonrotoclax to Treat Relapsed/Refractory Mantle Cell Lymphoma
The priority review positions sonrotoclax to potentially become the first BCL2 inhibitor approved in the U.S. for relapsed or refractory mantle cell lymphoma, offering a promising new option for patients with this aggressive and hard-to-treat cancer.
Center For Drug Evaluation (CDE) | 28/11/2025 | By Dineshwori
Akeso's Ivonescimab Wins 4th Breakthrough Therapy Nod in China for TNBC
Akeso has secured its fourth Breakthrough Therapy Designation (BTD) in China for Ivonescimab, targeting first-line treatment of triple-negative breast cancer (TNBC). The ongoing Phase III HARMONi-BC1 trial is assessing its safety and efficacy in this hard-to-treat cancer type.
Center For Drug Evaluation (CDE) | 03/11/2025 | By Dineshwori | 101
NMPA Clears Zhimeng Biopharma's Drug for Phase-II Epilepsy Trial
Zhimeng Biopharma’s drug for Phase II epilepsy trial will be evaluated in a randomized, double-blind, placebo-controlled multinational study to test its efficacy, safety, and tolerability as an adjunct therapy in adults with focal epilepsy.
Center For Drug Evaluation (CDE) | 13/09/2025 | By Dineshwori | 101
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy