CDE Releases Draft Guidelines on New Drug Benefit-Risk Assessment
The Center for Drug Evaluation (CDE) has released the “New Drug Benefit-Risk Assessment Technical Guidelines,”...
CDE
CDE Releases Guidelines on Pediatric Anti-tumor Drug Development
The Center for Drug Evaluation (CDE) has released a Technical Guidelines document focused on “Clinical...
Innovent’s Parsaclisib Filed for Marketing Approval in China
China’s Center for Drug Evaluation (CDE) has received a marketing approval application for Innovent Biologics...
Abbisko’s ABSK021 Gets CDE Approval for Phase III Study in Giant Cell Tumor of Tendon Sheath
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval...
CDE Releases Draft Guidelines for Tumor Therapeutic Vaccine Clinical Trials
The Center for Drug Evaluation (CDE) has released the “Tumor Therapeutic Vaccines Clinical Trial Technical...
CDE Releases 63rd Batch of Chemical Generic Reference Preparations
The Center for Drug Evaluation (CDE) has released the 63rd batch of chemical generic reference...
Telix Pharmaceuticals Gains IND Approval for TLX250-CDx in China
Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that it has received Investigational New Drug...
CDE Issues Guidelines for Anti-Tumor ADC Clinical Development
The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Clinical Research and...
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...
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...