AstraZeneca’s IMFINZI-BCG Combination Approved for High-Risk Non-Muscle-Invasive Bladder Cancer in US
AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved IMFINZI...
Drug
Merck’s Calderasib-Pembrolizumab Combination Receives FDA Breakthrough Therapy Designation for First-Line KRAS G12C-Mutant NSCLC
Merck & Co., Inc. (MSD; NYSE: MRK) announced that the U.S. Food and Drug Administration...
Eli Lilly’s Retevmo Shows 83% Risk Reduction in Disease Recurrence for Early-Stage RET Fusion-Positive NSCLC in Phase 3 LIBRETTO-432 Trial
Eli Lilly and Company (NYSE: LLY) announced groundbreaking results from the Phase 3 LIBRETTO-432 clinical...
Teligene’s TL118 Enters NMPA’s SPARK Initiative for Pediatric Cancer Treatment Development
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has included...
FDA Proposes Streamlined Animal Testing Requirements for Oncology Drugs to Accelerate Development Timeline
The U.S. Food and Drug Administration (FDA) released draft guidance aimed at reducing unnecessary animal...
Sanofi’s Venglustat Receives FDA Priority Review and Breakthrough Therapy Designation for Type 3 Gaucher Disease
Sanofi (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has granted priority...
BeOne Medicines and Amgen’s Tarlatamab Receives NMPA Conditional Approval for Second-Line ES-SCLC in China
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), formerly BeiGene, announced it has received...
Northland Biotech’s Engensis Gene Therapy Receives NMPA Approval for Severe Lower Limb Ischemia Ulcers
Beijing Northland Biotechnology Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted...
AstraZeneca’s Fasenra Becomes First Biologic Approved in China for Hypereosinophilic Syndrome
AstraZeneca PLC (NYSE: AZN) announced it has received marketing clearance from China’s National Medical Products...
Shionogi’s Symproic (Naldemedine) Receives NMPA Approval for Opioid-Induced Constipation in China
Shionogi & Co., Ltd. (TYO: 4507) announced that China’s National Medical Products Administration (NMPA) has...
Sino Biopharmaceutical’s IDH1 Inhibitor TQB3454 Receives NMPA Priority Review for Biliary Tract Cancer
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Ltd. (HKG:...
InnoCare Pharma’s BTK Inhibitor Orelabrutinib Gains NMPA Review Acceptance for Primary Immune Thrombocytopenia Indication
InnoCare Pharma Limited (HKG: 9969, SHA: 688428) announced that the Center for Drug Evaluation (CDE)...
Salvectors Receives NMPA Clinical Approval for YB1-X7, World’s First Oncolytic Salmonella Therapy for Advanced Solid Tumors
Salvectors, a China-based oncolytic bacteria therapy developer, announced it has received tacit clinical approval from...
Henlius Biotech Initiates China Dosing in Phase II/III Trial of Novel PD-L1 ADC HLX43 for Squamous NSCLC
Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing in China for an...
Hengrui Pharmaceuticals Receives NMPA Approval to Study SHR-1819 in Pediatric Atopic Dermatitis, Challenging Sanofi’s Dupilumab
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received approval from...
Sino Biopharmaceutical and GSK Report 19% Functional Cure Rate with Bepirovirsen in Phase III Hepatitis B Studies at EASL 2026
Sino Biopharmaceutical Limited (HKG: 1177) announced positive results from two Phase III clinical studies, B-Well...
Konruns Pharmaceutical to Present Promising Phase II KC1036 Data in Advanced Thymic Tumors at ASCO 2026
Konruns Pharmaceutical Co., Ltd. (SHA: 603590) announced plans to present results from a Phase II...
J&J Secures FDA Approval for TREMFYA Label Expansion to Include Structural Joint Damage Inhibition in Psoriatic Arthritis
Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA)...
Antengene Receives NMPA Approval for Phase III CLINCH-3 Trial of ATG-022 – CLDN18.2-Targeted ADC Advances in Gastric Cancer with Multi-Region Clinical Strategy
Antengene Corporation Limited (HKG: 6996) announced that China’s National Medical Products Administration (NMPA) has granted...
Sino Biopharmaceutical Presents Promising Phase I Data for Kylo-0603 at EASL 2026 – THR-β Agonist Shows 28.5% LDL-C Reduction with Favorable Safety Profile
Sino Biopharmaceutical Limited (HKG: 1177) announced the presentation of first-in-human Phase I clinical study results...