CF PharmTech’s Inhaled siRNA Therapy ICF004 Receives NMPA Clinical Approval for Interstitial Lung Disease
CF PharmTech Inc. (HKG: 2652) announced that China’s National Medical Products Administration (NMPA) has granted...
Drug
Shandong Boan Submits Dual Denosumab Biosimilar BLAs to FDA for Osteoporosis and Oncology Indications
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced the submission of Biologics License Applications (BLAs)...
Henlius Biotech’s Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has...
Chengdu Kanghua Initiates Phase II Trial for RSV mRNA Vaccine Through NanoRibo Acquisition in China’s Untapped Market
Chengdu Kanghua Biological Products Co., Ltd. (SHE: 300841) announced the initiation of a Phase II...
AbbVie’s VENCLYXTO Receives European Commission Approval for Two Novel Fixed-Duration Combinations in First-Line CLL Treatment
AbbVie (NYSE: ABBV) announced that the European Commission (EC) has granted an expanded marketing authorization...
Beijing Wantai’s 9-Valent HPV Vaccine Achieves Nationwide Distribution Across 13,000 Vaccination Sites in China
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. (SHA: 603392) announced the nationwide commercial launch of...
Bristol-Myers Squibb’s Mezigdomide-Kd Combination Shows 52% Risk Reduction in Relapsed Multiple Myeloma in Phase 3 SUCCESSOR-2 Trial
Bristol-Myers Squibb (BMS; NYSE: BMY) announced positive late-breaking results from the Phase 3 SUCCESSOR-2 trial...
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...
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...