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...
Product approvals
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...
Novartis’ Remibrutinib Wins NMPA Approval for Chronic Spontaneous Urticaria
Novartis AG (NYSE: NVS) announced that remibrutinib tablets received National Medical Products Administration (NMPA) approval...
Otsuka’s VOYXACT Wins FDA Accelerated Approval for IgAN, First APRIL Blocker
Otsuka Pharmaceutical (OTCMKTS: OTSKY) announced that VOYXACT (sibeprenlimab‑szsi) received U.S. FDA Accelerated Approval for reducing...
Novartis’s Itvisma Wins FDA Approval as First Gene Therapy for SMA
Novartis AG (NYSE: NVS) announced that Itvisma (onasemnogene abeparvovec‑brve) received U.S. FDA approval for children...
Novo’s Kyinsu Wins EU Approval for Type 2 Diabetes, a Once-Weekly Combo First
Novo Nordisk A/S (NYSE: NVO) announced that the European Commission (EC) has granted marketing authorization...
AstraZeneca’s Durvalumab Wins China Approval for Stage III NSCLC After Sequential Chemoradiotherapy
AstraZeneca (AZ, NASDAQ: AZN) announced that Imfinzi (durvalumab) received National Medical Products Administration (NMPA) approval...
CStone’s Sugemalimab Wins EU Approval for Stage III NSCLC, Expanding European Indication
CStone Pharmaceuticals (HKG: 2616) announced that the European Commission (EC) has approved a new indication...
Bayer’s HYRNUO Wins FDA Approval for HER2-Mutated Lung Cancer
Bayer AG (ETR: BAYN) announced that sevabertinib (trade name HYRNUO) received U.S. FDA approval for...