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...
Product approvals
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...
Jiuzhou Pharmaceutical Wins Tentative FDA Approval for Generic Janumet XR
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (SHA: 603456) announced that its Abbreviated New Drug Application (ANDA)...
Juventas CAR-T Wins Second China Approval for Lymphoma, Expands Hematology Franchise
Juventas Cell Therapy Ltd. announced that inaticabtagene autoleucel (CNCT 19), China’s first self‑developed CD19‑targeting CAR‑T...
Innovent’s Picankibart Wins NMPA Approval for Psoriasis as IL-23p19 Inhibitor
Innovent Biologics, Inc. (HKG: 1801) announced that Picankibart Monoclonal Antibody Injection (IBI112), branded XINMEIYUE, received...
Boan Biotech’s Boyoujing Aflibercept Wins NMPA Approval for Retinal Diseases
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that its self‑developed Aflibercept Intravitreal Injection (Boyoujing)...
MicroTech’s LinX CGM Wins India Approval, Expanding Asia Diabetes Monitoring
MicroTech Medical (Hangzhou) Co., Ltd. (HKG: 2235) announced that its LinX Continuous Glucose Monitoring (CGM)...
Bio-heart’s IberiRDN Wins New Zealand Nod as Only Dual-Approach Renal Denervation System
Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced that its Iberis Multi-Electrode Renal Denervation...