CDE

Company Drug

CSPC Pharmaceutical’s JMT103 Anti-RANKL Antibody Prioritized for CDE Review

Fineline Cube Jul 11, 2022

China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its market filing for JMT103, an...

Policy / Regulatory R&D

CDE Releases 60th Batch of Chemical Generic Reference Preparations

Fineline Cube Jul 6, 2022

The Center for Drug Evaluation (CDE) has released the 60th batch of chemical generic reference...

Policy / Regulatory

CDE Releases 58th and 59th Batches of Chemical Generic Reference Preparations

Fineline Cube Jun 20, 2022

The Center for Drug Evaluation (CDE) has released the 58th and 59th batches of chemical...

Company Drug

Haisco Pharmaceutical Wins NMPA Clinical Approval for Nav1.8 Inhibitor HSK51155 – Pain Drug Licensed to AbbVie in USD 700 Million Deal Advances in China

Company Drug

Lepu Medical’s siRNA Drug MWN117 Wins NMPA Clinical Trial Approval for Overweight and Obesity – INHBE‑Targeting Therapy Shows Synergy Potential with GLP‑1 Agonists

Policy / Regulatory

FDA Issues Discussion Paper on GenAI‑Enabled Medical Devices – Seeks Feedback on Risk Framework, Premarket Evaluation and Postmarket Monitoring by October 19

Company Medical Device

Johnson & Johnson Wins U.S. 510(k) Clearance for MONARCH QUEST 3 Software Update – Advancing Robotic Bronchoscopy Navigation and Targeting