CDE Issues Guidelines for Real-World Drug Research and Evidence Framework
The Center for Drug Evaluation (CDE) has released two important documents: the “Guiding Principles of...
CDE
Betta Pharmaceuticals’ BPI-D0316 Accepted for Review by CDE for First-Line NSCLC
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that another market approval filing for...
CDE Releases 66th Batch of Chemical Generic Reference Preparations
The Center for Drug Evaluation (CDE) has released the 66th batch of chemical generic reference...
CDE Releases 65th Batch of Chemical Generic Reference Preparations
The Center for Drug Evaluation (CDE) has released the 65th batch of chemical generic reference...
China’s NMPA Shifts to Electronic Drug Filings from January 2023
China’s National Medical Products Administration (NMPA) has released a notification indicating the initiation of electronic...
Frontier Biotechnologies Gains CDE Approval for FB2001 COVID-19 Inhalant Study
China-based Frontier Biotechnologies Inc. (SHA: 688221) has announced receiving approval from the Center for Drug...
Salubris Pharmaceuticals’ SAL0119 Accepted for CDE Review in China
China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that its clinical trial filing...
China’s CDE, HNMPA, and Bo’ao Lecheng Release Real-world Drug Research Measures
The Center for Drug Evaluation (CDE), Hainan Medical Products Administration (HNMPA), and Bo’Ao Lecheng Medical...
CDE Issues Trial Rules for NMPA Drug Review Timekeeping Suspension
The Center for Drug Evaluation (CDE) has released the “NMPA Drug Review Timekeeping Suspension and...
CDE Issues Guidelines for Bispecific Antibody Antitumor Drug Development
The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Clinical Research and...
CDE Seeks Public Feedback on New Drug Benefit-Risk Assessment Guidelines
The Center for Drug Evaluation (CDE) has released the “New Drug Benefit-Risk Assessment Technical Guidelines,”...
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 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...