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...
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...
NMPA Opens 2026 National Reimbursement Drug List Application Window with Revised Eligibility Criteria and Price Controls
China’s National Medical Products Administration (NMPA) has released the “2026 Adjustment Work Plan for the...
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The U.S. Food and Drug Administration (FDA) released draft guidance aimed at reducing unnecessary animal...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:...
Sihuan Pharmaceutical and dProtein Biotechnology Form AI-Powered Medical Aesthetics Joint Venture
Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced plans to establish a joint venture (JV)...
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...
Kexing Pharmaceutical and Sinotherapeutics Partner to Commercialize Tofacitinib Extended-Release Tablets in Kuwait and Mexico
Kexing Pharmaceutical (SHA: 688136) and Sinotherapeutics Inc. (SHA: 688247) have announced a joint commercialization agreement...
Genrix Bio Licenses BCMA×CD3 Bispecific Velinotamig to Fosun’s Yaopharma for Greater China in $268M Deal
Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) announced a licensing agreement with Yaopharma Co.,...
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...