Takeda Secures NMPA Approval for Adzynma – China’s First Recombinant ADAMTS13 Therapy for Congenital TTP
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that China’s National Medical Products Administration...
Product approvals
Gilead’s Trodelvy (Sacituzumab Govitecan) Secures European Commission Approval for First-Line Metastatic TNBC – Expanding ADC Access to Treatment-Naïve Patients
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the European Commission (EC) has granted marketing authorization...
Henlius and Organon Canada Launch Denosumab Biosimilars BILDYOS and TUZEMTY – Expanding Access to Bone-Targeted Therapies Across All Canadian Indications
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon Canada announced the official commercial launch of...
AbbVie’s SKYRIZI (Risankizumab) Secures European Commission Approval for Pediatric Plaque Psoriasis – First IL-23 Inhibitor Authorized for Children as Young as Six
AbbVie Inc. (NYSE: ABBV) announced that the European Commission (EC) has granted marketing authorization for...
Sanofi’s Wayrilz (Rilzabrutinib) Secures Japanese Approval for Immune Thrombocytopenia – Expanding Global Footprint Across Six Major Markets
Sanofi S.A. (NASDAQ: SNY) announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved...
China Medical System’s Silvemimab Becomes World’s First Dual-Epitope Fully Human Rabies Antibody Approved in China
China Medical System Holdings Limited (HKG: 0867) announced that the National Medical Products Administration (NMPA)...
Biokin Secures World’s First EGFR×HER3 Bispecific ADC Approval with Loncomystatug Deruxtecan for Nasopharyngeal Carcinoma
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its first-in-class (FIC) Class 1 therapeutic...
Pierre Fabre Secures European Commission Approval for Braftovi Combination in BRAF-Mutant Colorectal Cancer
Pierre Fabre announced that the European Commission (EC) has approved Braftovi (encorafenib) in combination with...
CARsgen Therapeutics Secures World’s First Solid Tumor CAR-T Approval with Kylimei for Gastric Cancer
CARsgen Therapeutics Holdings Limited (HKG: 2171) announced that its CAR-T therapy Kylimei (satricabtagene autoleucel injection)...
Gan & Lee Pharmaceuticals Secures UAE Approval for Insulin Glargine Prefilled Pen, Expanding Global Diabetes Portfolio
Gan & Lee Pharmaceuticals (SHA: 603087) announced that the Ministry of Health and Prevention (MOHAP)...
MicroPort MedBot’s Toumai Remote Surgical Robot Achieves World’s First CE Certification for Multi-Specialty Robotic Surgery
Shanghai MicroPort MedBot (Group) Co., Ltd. (HKG: 2252) announced that its Toumai laparoscopic surgical robot...
Jenscare’s Ken-Valve TAVR System Gains Hong Kong Approval for Aortic Regurgitation Following Mainland China Launch
Jenscare Scientific Co., Ltd. (HKG: 9877), a leading Chinese structural heart disease device manufacturer, announced...
IASO Biotherapeutics’ Fucaso Becomes First BCMA CAR-T Therapy Approved in Singapore for Relapsed/Refractory Multiple Myeloma
IASO Biotherapeutics announced that Singapore’s Health Sciences Authority (HSA) has approved the New Drug Application...
Sanofi’s Sarclisa Subcutaneous Formulation Approved in Japan for Multiple Myeloma Across Treatment Settings
Sanofi (NASDAQ: SNY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved...
Merck’s Capvaxive Pneumococcal Vaccine Expands to Pediatric Population with FDA Approval for Ages 2-17
Merck & Co., Inc. (MSD, NYSE: MRK), known as MSD outside the United States, announced...
GSK and Spero Therapeutics Secure FDA Approval for Utebzi, First Oral Carbapenem Antibiotic for Complicated UTIs
GlaxoSmithKline plc (GSK) (NYSE: GSK) and Spero Therapeutics (NASDAQ: SPRO) announced that the U.S. Food...
Hengrui Pharmaceuticals Expands Dalpiciclib Label with NMPA Approval for Early Breast Cancer Adjuvant Therapy
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received additional indication...
Regent Pacific’s Senstend Receives NMPA Approval with Four-Year Data Protection, Triggering $5M Milestone Payment from Wanbang
Regent Pacific Group Limited (HKG: 0575) announced that the New Drug Application (NDA) for its...
Zelgen Biopharmaceuticals Secures NMPA Approval for Zepuping in Severe Alopecia Areata – First Immuno-Inflammatory Indication for Pan-JAK Inhibitor
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that the National Medical Products Administration (NMPA)...
BMS Secures NMPA Approval for Sotyktu in Psoriatic Arthritis – First Selective TYK2 Inhibitor Expands China Indications
Bristol-Myers Squibb (BMS, NYSE: BMY) announced that China’s National Medical Products Administration (NMPA) has granted...