CDE Releases 62nd Batch of Chemical Generic References, Updates 39 Specifications
The Center for Drug Evaluation (CDE) has released the 62nd batch of chemical generic reference...
CDE
Staidson and J&J’s Teclistamab Gain Breakthrough Designation for Hemophilia and Myeloma
The Center for Drug Evaluation (CDE) has indicated that Staidson (Beijing) Pharmaceutical Co., Ltd’s (SHE:...
CDE Releases Draft Guidelines for RWE-Backed Drug Registration Applications
The Center for Drug Evaluation (CDE) has released a notification regarding the “Real-World Evidence (RWE)-backed...
CDE Issues Q&As on COVID-19 Antiviral Drug Evaluation Criteria
The Center for Drug Evaluation (CDE) has published a list of Q&As regarding the non-clinical...
CDE Releases 61st Batch of Generic Reference Preparations, 34 New Specs Added
The Center for Drug Evaluation (CDE) has released the 61st batch of chemical generic reference...
CSPC Pharmaceutical’s JMT103 Anti-RANKL Antibody Prioritized for CDE Review
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its market filing for JMT103, an...
CDE Releases 60th Batch of Chemical Generic Reference Preparations
The Center for Drug Evaluation (CDE) has released the 60th batch of chemical generic reference...
CDE Releases 58th and 59th Batches of Chemical Generic Reference Preparations
The Center for Drug Evaluation (CDE) has released the 58th and 59th batches of chemical...