Shanghai Pharmaceuticals Receives Thai FDA Approval for Pregabalin Capsules
China-based Shanghai Pharmaceuticals Holding Co., Ltd (SPH, HKG: 2607, SHA: 601607) announced that it has...
Product approvals
Gilead’s Yeztugo Approved by FDA as First Six-Monthly Injectable HIV PrEP
US-based Gilead Sciences, Inc. (NASDAQ: GILD) announced that it has received market approval from the...
Merck’s Clesrovimab Gears Up for Priority Review in China for RSV Prevention
China’s Center for Drug Evaluation (CDE) website indicates that US giant Merck, Sharp & Dohme’s...
Allgens Medical’s SkuHeal Artificial Bone Repair Material Gains Vietnam Marketing Approval
Beijing-based regenerative medicine materials and implantable device maker Allgens Medical Technology Co., Ltd (SHA: 688613)...
RemeGen’s Telitacicept Receives Orphan Drug Designation for Myasthenia Gravis in Europe
China-based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) announced that it has received orphan drug...
Santen’s Ryjunea Gets EU Approval to Slow Myopia Progression in Children
Japan-based Santen Pharmaceutical Co., Ltd. announced that it has received marketing approval from the European...
Pediatrix Therapeutics Wins Macau Approval for Neffy Epinephrine Nasal Spray
China-based Pediatrix Therapeutics announced that it has received marketing approval in Macau for its neffy...
Minova Pharmaceuticals Launches Rongzhi, China’s First Injectable Adipocytolytic Drug
Nanjing-based Minova Pharmaceuticals Co., Ltd announced last week that it has received marketing approval from...
Fosun Pharma’s Serplulimab Approved in Singapore and Malaysia for ES-SCLC Treatment
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that its subsidiary Shanghai...
FDA OKs MSD’s Keytruda for Perioperative Head and Neck Cancer Treatment With PD-L1 Expression
US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) announced that the US Food...
MSD Wins NMPA Approval for Keytruda-Lenvima Combo in Hepatocellular Carcinoma
US-based Merck, Sharp & Dohme (MSD; NYSE: MRK) announced that China’s National Medical Products Administration...
AbbVie’s Mavyret Gains FDA Approval for Acute HCV in Children and Adults
US-based AbbVie (NYSE: ABBV) announced that the US Food and Drug Administration (FDA) has approved...
BeOne Medicines Wins FDA Approval for Brukinsa Tablet Across All Five Indications
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that it has received...
Lilly Launches Mounjaro Multi-Dose Pen in China for Diabetes and Weight Management
US-based Eli Lilly & Co. (NYSE: LLY) announced the launch of Mounjaro (tirzepatide multi-dose prefilled...
Varian Medical Systems Secures NMPA Approval for Ethos 2.0 AI Radiotherapy Platform
US-based Varian Medical Systems (NYSE: VAR) announced that it has received marketing approval from China’s...
China’s Sichuan Kelun-Biotech Wins BTD for Sac-TMT in Non-Squamous NSCLC
China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that its core product Jiatailai (sacituzumab...
Sihuan Pharma’s Xuanyuening Granted New Indication Review in China
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that the National Medical Products Administration...
Innovent Biologics’ Xinbiyue Approved for Macau Market
China-based Innovent Biologics Inc. (HKG: 1801) announced that it has received market approval from the...
FDA Approves Merck’s Enflonsia for Infant RSV Protection
The US Food and Drug Administration (FDA) granted approval to Merck, Sharp & Dohme’s (MSD;...
Genesis MedTech Wins NMPA Approval for Locally Developed Thrombus Aspiration Catheter
Singapore-based Genesis MedTech announced that it has received marketing approval from China’s National Medical Products...