Biogen and Samsung Bioepis Win EC Approval for Opuviz Biosimilar in Europe
US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced...
Product approvals
AbbVie’s Elahere Receives EC Approval for FRα-Positive Ovarian Cancer Treatment
US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug...
Everest Medicines’ Nefecon Receives Full Approval from South Korea’s MFDS for IgAN Treatment
China-based Everest Medicines (HKG: 1952) has announced that it has received full approval from the...
Sandoz Receives EC Approval for Biosimilar to Eylea for Retinal Diseases
Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced that it has received marketing approval from...
Shanghai Junshi Biosciences’ Toripalimab Wins UK Approval for Nasopharyngeal and Oesophageal Cancers
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in...
GE Healthcare’s SIGNA MAGNUS MRI Scanner Receives FDA 510(k) Clearance
US medical device and life sciences leader GE Healthcare Technologies Inc. (NASDAQ: GEHC) has announced...
Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE...
Cutia Therapeutics’ CU-10201 Receives NMPA Approval for Acne Vulgaris Treatment
Cutia Therapeutics (HKG: 2487), a developer of dermatology therapies, has announced that its CU-10201, a...
Sino Medical Sciences Technology Secures Marketing Approval in Peru for HT Supreme Stent System
Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical technology company, has announced...
Sino Biopharmaceutical Ltd Receives NMPA Approval for KRAS G12C Inhibitor Garsorasib
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced that it...
Johnson & Johnson MedTech’s Varipulse Platform Receives FDA Approval for Atrial Fibrillation Treatment
Johnson & Johnson MedTech (J&J, NYSE: JNJ) has announced that it has received marketing approval...
Bayer AG Receives FDA 510(k) Clearance for MEDRAD Centargo CT Injection System
Germany-based Bayer AG (ETR: BAYN) has announced that it has received 510(k) clearance from the...
Pfizer’s Talzenna (talazoparib) Approved by China’s NMPA for mCRPC Treatment
The National Medical Products Administration (NMPA) website has indicated that Pfizer’s (NYSE: PFE) marketing filing...
Sanofi’s Dupixent Gains EMA Approval for Eosinophilic Esophagitis in Children
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from...
Amgen’s Tavneos Receives NMPA Approval for ANCA-Associated Vasculitis Treatment in China
US biotechnology company Amgen (NASDAQ: AMGN) has announced that it has received market approval in...
Changchun High & New Technology Industries Receives NMPA Approval for Long-Acting Somatropin
Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading China-based company, has...
Huadong Medicine Co., Ltd Receives NMPA Approval for Stelara Biosimilar SaiLeXin
Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has...
China Medical System’s Opzelura Approved in Hong Kong for Non-segmental Vitiligo Treatment
China Medical System Holdings (CMS; HKG: 0867) has announced that the market filing for its...
Asieris Pharmaceuticals Receives NMPA Approval for Hexvix (APL-1706) in Bladder Cancer Diagnosis
China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced that the National Medical Products...
BMS’s Opdivo Secures NMPA Approval for Urothelial Carcinoma Treatment
Bristol Myers Squibb (BMS; NYSE: BMY) has announced that it has received another indication approval...