China’s NMPA Grants Medical Device License to DaAn Gene’s Monkeypox Detection Kit
GUANGZHOU—DaAn Gene Co., Ltd, a subsidiary of Sun Yat-sen University based in China (SHE: 002030),...
Product approvals
Changchun High & New Technology Secures NMPA Approval for Turner Syndrome Treatment
CHANGCHUN—Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading biopharmaceutical company in...
AstraZeneca’s Fasenra Secures NMPA Approval for Severe Eosinophilic Asthma Maintenance Therapy
BEIJING—The National Medical Products Administration (NMPA) of China has granted market approval for AstraZeneca (NASDAQ:...
Genmab’s Tepkinly/Epkinly Receives EC Nod for Relapsed Lymphoma Treatments
COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC)...
Lepu Medical Secures Approval for RECATCHOR Catheter, Enhancing Cardiovascular Procedures
Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions...
Robotrak Secures NMPA License for China’s First Smart Ophthalmic Navigation Laser
Robotrak, a Nanjing-based ophthalmic innovation platform, has secured a Category III medical device license from...
Lepu Scientech Secures NMPA Approval for MemoSORB Biodegradable Atrial Septal Defect Occluder
Lepu Scientech Medical Technology (Shanghai) Co., Ltd. (HKG: 2291) has announced that it has received...
Sino Medical Secures Moroccan Approvals for NC Rockstar Catheter and HT Supreme Stent System
Sino Medical Sciences Technology Inc. (SHA: 688108), a prominent player in China’s medical device sector,...
Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy
Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the...
Biogen and Eisai Secure UAE Approval for Alzheimer’s Therapy Leqembi
Biogen Inc. (NASDAQ: BIIB), based in the U.S., and Japan’s Eisai Co., Ltd. have announced...
China’s Sansure Biotech Launches Approved Kit for Alzheimer’s and Cardiovascular Risk Assessment
Sansure Biotech Inc. (SHA: 688289), a China-based leader in molecular diagnostics, has secured marketing approval...
Qilu Pharmaceutical Gains Approval for Generic Dasatinib, Expanding CML Treatment Options in China
Qilu Pharmaceutical, based in China, has received marketing approval for its generic version of Bristol-Myers...
Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer
Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and...
Lepu Medical’s PeakHeat Vascular Sheath Gains Regulatory Green Light for Market Launch
Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions...
Sihuan Pharmaceutical Secures NMPA Approval for First Biosimilars of Novo Nordisk’s Diabetes Drugs
Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has secured separate marketing approvals from China’s National...
Ascendis Pharma’s Hypoparathyroidism Therapy Yorvipath Wins FDA Nod, Fills Market Gap
This week, the U.S. Food and Drug Administration (FDA) granted market approval to Ascendis Pharma...
Artech Medical’s Balloon Cryoablation Catheter Wins NMPA Nod for Atrial Fibrillation Treatment
Shanghai Artech Medical Technology Co., Ltd., a company known for its innovation in the medical...
Chinese NMPA Approves Hengrui Pharmaceuticals’ Generic Abraxane for Metastatic Pancreatic Cancer Treatment
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced...
Guangdong Zhongsheng Pharmaceutical’s COVID-19 Drug Leritrelvir Approved in Macau
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a pharmaceutical company based in China, has announced...
Sansure Biotech’s MTHFR Gene Detection Kit Receives NMPA Approval, Aids in Pregnancy Health Management
Sansure Biotech Inc. (SHA: 688289), a specialist in molecular diagnostics based in China, has achieved...