Sino Biopharmaceutical’s TQ-B3101 Accepted by NMPA for ROS1+ NSCLC Treatment
China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that the National Medical Products Administration (NMPA)...
Market approval filings
BeiGene’s Tislelizumab Accepted for Review in Gastric Cancer Treatment
BeiGene (NASDAQ: BGNE) announced that a supplementary Biologic License Application (sBLA) for its programmed death-1...
CSPC’s JMT103 Accepted for Review in China, Targets RANKL-Related Deficiencies
The Center for Drug Evaluation (CDE) website indicates that a market filing by China-based CSPC...
Takeda’s Obizur Accepted by China’s NMPA for Acquired Hemophilia A Treatment
Takeda Pharmaceutical Co., Ltd’s (NYSE: TAK, TYO: 4502) China unit announced that a New Drug...
Hansoh Pharmaceutical’s Ameile Accepted for UK Regulatory Review
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a Marketing Authorization Application (MAA)...
Innovent Biologics’ IBI306 Accepted for Review by China’s NMPA for Hypercholesterolemia
China-based Innovent Biologics Inc. (HKG: 1801) has announced that a New Drug Application (NDA) filing...
Novartis’ Tislelizumab Faces FDA Hurdle in First-Line NSCLC Monotherapy
Novartis disclosed during its Q2 2022 earnings call that the U.S. FDA deemed clinical data...