MSD’s Welireg Gains FDA Approval for Advanced Renal Cell Carcinoma
The US Food and Drug Administration (FDA) has granted an indication extension approval for Merck,...
Product approvals
MicroPort MedBot’s R-ONE Vascular Intervention Robot Approved by China’s NMPA
Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received market...
Sino Medical Sciences Secures Market Approvals in Hong Kong, China, and Malaysia for Medical Devices
China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approvals for two...
Luye Pharma’s Lurbinectedin Receives Market Approval in Hong Kong for SCLC Treatment
China-based Luye Pharma Group (HKG: 2186) has announced that Hong Kong’s pharmacy and poisons board...
Cryofocus Medtech Receives NMPA Approval for Complete Cardiac Cryoablation System
Cryofocus Medtech (Shanghai) Co., Ltd. (HKG: 6922), a Shanghai-based specialist in cryoablation treatment, has announced...
Zylox-Tonbridge Medical Technology’s ZENFLOW T18 Receives NMPA Marketing Approval
Zylox-Tonbridge Medical Technology (HKG: 2190), a developer of nerve and peripheral vascular interventional devices based...
Pfizer and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC
Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National...
AK Medical Secures NMPA Approval for Advanced 3D-Printed Hip Prosthesis Component
China-based AK Medical Holdings Ltd (HKG: 1789) has announced that it has received market approval...
Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the...
Antengene Secures NDA Approval for Xpovio in Macau for Advanced Multiple Myeloma
Antengene Corp., Ltd. (HKG: 6996), a biopharmaceutical company based in China, has announced that it...
Novartis’ Fabhalta Wins FDA Nod as First-in-Class Treatment for Paroxysmal Nocturnal Hemoglobinuria
Swiss pharmaceutical giant Novartis (NYSE: NVS) has secured regulatory approval from the US Food and...
Sinocare Inc’s Blood Glucose Monitoring System Earns US FDA Approval
Sinocare Inc (SHE: 300298), a Chinese medical device company, has announced that it has received...
Jingxin Pharmaceutical’s Didaxini Gains NMPA Approval as Category 1 Drug
Jingxin Pharmaceutical Co., Ltd (SHE: 002020), a Chinese pharmaceutical company, has announced that it has...
Sino Medical Secures Market Approval in Taiwan for NC Rockstar Coronary Catheter
Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that its NC Rockstar non-compliant coronary...
Luye Pharma’s Lurbinectedin for Metastatic SCLC Wins Macau Regulatory Nod
Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that Macau’s medical products...
Tonghua Dongbao Pharmaceuticals Secures NMPA Approval for Biosimilar Liraglutide
Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced that it has received...
Nanchang Baiji Pharmaceutical’s Budesonide Nasal Spray Approved by China’s NMPA
Nanchang Baiji Pharmaceutical Co. Ltd., a Chinese pharmaceutical company, has received approval from the National...
Eli Lilly’s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia
The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated...
Valgen Secures NMPA Approval for China’s First Transcatheter Mitral Valve Clamp System
Hangzhou-based Valgen Holding Corporation has received market approval from the National Medical Products Administration (NMPA)...
Ambio Gains FDA Approval for Generic Forteo, Challenging Eli Lilly’s Osteoporosis Market
Ambio has secured regulatory approval from the U.S. Food and Drug Administration (FDA) for its...