BeiGene’s Tevimbra Receives FDA Approval for ESCC Treatment
BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), a multinational oncology company planning to change...
Product approvals
Genentech’s TNKase Approved by FDA for Acute Ischemic Stroke Treatment
Genentech, a subsidiary of Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), announced that its thrombolytic...
Waters and Kehua’s LC-MS Systems Gain NMPA Approval for IVD Use
Two home-grown liquid chromatography with tandem mass spectrometry (LC-MS) systems, the ACQUITY UPLC I-Class PLUS...
Zai Lab’s Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received marketing...
Zeiss Group’s VISUMAX 800 with SMILE pro Software Approved by China’s NMPA
Germany-based Zeiss Group, a specialist in optical systems and optoelectronic product manufacturing, announced that it...
Sinocelltech’s Finotonlimab Gets NMPA Approval for Liver Cancer Treatment
China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received another indication approval from...
Shanghai Moyang Biotech’s Aphranel CC Needle Wins NMPA Approval
China-based Shanghai Moyang Biotechnology Co., Ltd, an innovation-focused company in nanomedical biomaterials and Class III...
Hepalink Pharmaceutical’s Enoparin Receives Argentina Approval for Thromboembolic Diseases
China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that its subsidiary, Shenzhen Techdow...
Bio-heart’s Iberis System Approved by NMPA for Hypertension Treatment
China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced that its subsidiary, Shanghai Angiocare...
Fosun Pharma’s Tenapanor Approved in China for CKD Dialysis Patients
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received...
J&J’s Tremfya Wins NMPA Approval for Crohn’s Disease Treatment
Johnson & Johnson (J&J, NYSE: JNJ) announced that its Tremfya (guselkumab) has received marketing approval...
Sanofi’s Sarclisa Wins New Japan Approval for Multiple Myeloma Combination Therapy
Sanofi (EPA: SAN, NASDAQ: SNY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW)...
Sandoz Launches Pyzchiva Biosimilar of J&J’s Stelara in US
Switzerland-based Sandoz (SWX: SDZ) announced the launch of Pyzchiva, a biosimilar version of Johnson &...
Medtronic’s BrainSense Adaptive DBS Wins FDA Approval for Parkinson’s Treatment
US-Irish medical device giant Medtronic (NYSE: MDT) announced that the US Food and Drug Administration...
Takeda’s Takhzyro Receives EMA Approval for New Administration Form in HAE Patients
Japan-headquartered Takeda (NYSE: TAK, TYO: 4502) announced that the European Medicines Agency (EMA) has approved...
Meyer FSMP Hong Kong Secures NMPA Approval for First FSMP in Greater China
Hong Kong-based Meyer FSMP Hong Kong Limited, an oncology-focused foods for special medical purpose (FSMP)...
Subtle Medical Integrates DeepSeek with FDA-Approved SupMR AI Platform
Shanghai-based Subtle Medical Inc., an AI-powered medical imaging firm operating in the U.S. and China,...
MicroPort CardioFlow’s AnchorMan LAA Occluder System Earns CE Mark Approval
Hong Kong-listed MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) has received the CE mark for...
Roche’s Tecentriq Wins Japan Approval for Alveolar Soft Part Sarcoma
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) and its Japanese partner Chugai Pharmaceutical Co.,...
Gilead’s Livdelzi Receives Conditional EC Approval for Primary Biliary Cholangitis
US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that it has received conditional approval from the...