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...
Product approvals
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...
Roche cobas-liat Whooping-Cough Test Secures FDA Clearance
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that its cobas liat system-based point‑of‑care test for whooping...
CANbridge’s maralixibat Wins Hong Kong Approval for PFIC Cholestatic Pruritus
CANbridge Pharmaceuticals Inc. (HKG: 1228) announced that maralixibat has been approved by the Department of...
Johnson & Johnson’s Nipocalimab Secures EU Approval for Myasthenia Gravis
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission has granted Marketing Authorisation...
Microport’s PulseMagic PFA-Catheter Secures NMPA Approval as First Pressure-Monitoring Device in China
Shanghai Microport EP Medtech Co., Ltd (SHA: 688351) announced that its PulseMagic TrueForce Disposable Pressure-Monitoring...
Pfizer-Astellas’ PADCEV Wins FDA Approval for Perioperative Bladder Cancer
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TYO: 4503) announced that the U.S. Food...