FDA Approves AstraZeneca’s Datopotamab deruxtecan for EGFR-Mutated NSCLC
The US Food and Drug Administration (FDA) this week approved Datopotamab deruxtecan (Dato-DXd), a TROP-2-targeted...
Product approvals
Merck’s Prevymis Approved in China for Pediatric CMV Prevention
US-based pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that its novel non-nucleoside...
Sansure Biotech Wins NMPA Approval for Fungal Infection Detection Kit
China’s National Medical Products Administration (NMPA) has approved Sansure Biotech Inc.’s (SHA: 688289) Pneumocystis jirovecii,...
Broncus Medical Wins NMPA Approval for BroncAblate RFA System Console
Shanghai and Hangzhou (China), and San Jose and Seattle (United States)-based Broncus Medical (HKG: 2216)...
EMA Panel Recommends Bio-Thera’s Usymro for Autoimmune Diseases
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
J&J’s Darzalex SC Recommended by CHMP for High-Risk Smoldering Multiple Myeloma
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended...
Simcere Pharma’s Quviviq Receives NMPA Approval for Insomnia Treatment
Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) revealed that its marketing approval filing for Quviviq...
Sanofi and Regeneron Win FDA Approval for Dupixent in Bullous Pemphigoid Treatment
France major Sanofi (NASDAQ: SNY) and US-based biopharma Regeneron (NASDAQ: REGN) announced that Dupixent (dupilumab)...
Zai Lab’s Partner argenx Secures EU Approval for Vygart in CIDP Treatment
China-based Zai Lab Limited’s (NASDAQ: ZLAB, HKG: 9688) Dutch partner argenx SE (NASDAQ: ARGX) announced...
CanSino Biologics’ PCV13i Vaccine Gains NMPA Approval
China-based CanSino Biologics Inc., (HKG: 6185) announced that the National Medical Products Administration (NMPA) has...
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...
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...