Throat Cancer – PharmaLive

U.S. FDA declines to approve two more China-tested drugs

Business, China, Complete Response Letter, FDA, FDA Statements, Gastroenteropancreatic neuroendocrine tumors, Gastroenteropancreatic Neuroendocrine Tumors, Gastrointestinal Tumors, Lung Neuroendocrine Tumors, Nasopharyngeal Carcinoma (NPC), Neuroendocrine Tumors, Oncology, R&D, Shares, Therapeutics, Throat Cancer

The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies – Hutchmed Ltd. – needs to test its drug for the U.S. population in a diverse multi-regional trial.

Junshi’s Checkpoint Inhibitor Ready to Head to Regulators for Throat Cancer

Biologics License Application (BLA), Checkpoint Inhibitors, China, China National Medical Products Administration (NMPA), Clinical Trials, Conditional Approval, FDA/Regulatory, Interim Analysis, Nasopharyngeal Carcinoma (NPC), Progression-Free Survival (PFS), R&D, Throat Cancer

Junshi Biosciences, based in Shanghai, China, announced that an Independent Monitoring Committee (IDMC) decided the company’s Phase III JUPITER-02 trial had met the pre-specified primary endpoint at the interim analysis.