ENHERTU Wins FDA Approval as First-Line HER2 Breast Cancer Therapy
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) announced that ENHERTU (fam-trastuzumab deruxtecan-nxki) in...
Product approvals
GSK’s Nucala Wins CHMP Nod for COPD in Europe
UK biopharma GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the European Medicines Agency’s Committee for...
Novo Nordisk’s Wegovy 7.2mg Gets EMA Positive Opinion for Obesity
Novo Nordisk A/S (NYSE: NVO) announced that the European Medicines Agency’s Committee for Medicinal Products...
Innovent’s Mazdutide Wins Macau Approval for Weight Management
Innovent Biologics, Inc. (HKG: 1801) announced that mazdutide received marketing approval from Macau’s drug regulatory...
Amgen’s Uplizna Scores Third FDA Indication in Myasthenia Gravis
Amgen Inc. (NASDAQ: AMGN) announced that the U.S. FDA approved Uplizna (inebilizumab-cdon) for adult patients...
Peijia Medical Wins NMPA Approval for TaurusTrio TAV, First Transfemoral System for Aortic Regurgitation
Peijia Medical Limited (HKG: 9996) announced that China’s National Medical Products Administration (NMPA) approved the...
Joincare’s Pixavir Marboxil Wins NMPA Approval as First Single‑Dose Flu Treatment
Joincare Pharmaceutical Group Industry Co., Ltd. (SHA: 600380) announced that its Class 1 innovative drug, Pixavir...
InnoCare’s Zurletrectinib Wins NMPA Nod as China’s First Next-Gen TRK Inhibitor
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that its self‑developed next‑generation TRK inhibitor, Zurletrectinib...
Sino Biopharm’s Culmerciclib Wins NMPA Approval as First CDK2/4/6 Inhibitor for Breast Cancer
Sino Biopharmaceutical (HKG: 1177) announced that Culmerciclib Capsules, the world’s first CDK2/4/6 inhibitor, received marketing...
Shanghai Pharma’s SPH3127 Renin Inhibitor Wins NMPA Approval for Primary Hypertension
Shanghai Pharmaceuticals Holding Co., Ltd. (SHA: 601607) announced that the National Medical Products Administration (NMPA)...
Sanofi’s Qfitlia Wins China Approval as First Hemophilia siRNA Therapy
Sanofi (NASDAQ: SNY) announced that Qfitlia (Fitusiran Sodium Injection), the world’s first and only siRNA‑based...
Qilu Pharmaceutical Secures China Approval for Panitumumab N01, First Fully Human anti‑EGFR Antibody in Colorectal Cancer
Qilu Pharmaceutical Company Limited announced that its Panitumumab N01 Injection has received marketing approval from...
FDA Waskyra WAS Gene Therapy First Cell-Based
The US Food and Drug Administration (FDA) approved Waskyra (etuvetidigene autotemcel) as the first cell‑based...
FDA Omisirge Severe Aplastic Anemia First HSCT
The US Food and Drug Administration (FDA) approved Omisirge (omidubicel-onlv) as the first hematopoietic stem...
Ignis Therapeutics Cenobamate NMPA Approval Targets Epilepsy
Ignis Therapeutics announced that cenobamate tablets received marketing approval from China’s National Medical Products Administration...
Ignis Therapeutics Solriamfetol NMPA Approval Targets OSA Sleepiness
Ignis Therapeutics announced that Solriamfetol Hydrochloride Tablets received approval from China’s National Medical Products Administration...
Balance Medical ePTFE Pericardial-Membrane Gets NMPA Nod, Ends Import Reliance
Beijing Balance Medical Technology Co., Ltd. (SHA: 688198) announced that its expanded polytetrafluoroethylene (ePTFE) pericardial...
BMS Breyanzi MZL FDA Approval First CAR-T
Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel)...
Acotec V-otter Microcatheter Secures NMPA Approval for TACE Procedures
Acotec Scientific Holdings Limited (HKG: 6669) announced it has received registration approval from China’s National...
Antengene XPOVIO sNDA Hong-Kong Approval Expands MM DLBCL Indications
Antengene Corporation Limited (HKG: 6996) announced that Hong Kong’s Department of Health approved two supplementary...