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)...
Product approvals
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...
Pfizer’s Hympavzi Wins China Approval as First Weekly Non‑Factor Hemophilia Therapy
Pfizer Inc. (NYSE: PFE) announced that Hympavzi (marstacimab), the world’s first non‑factor hemophilia therapy requiring...
Regeneron’s Libtayo Wins EC Approval for Adjuvant CSCC, 68% Risk Reduction
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the European Commission (EC) approved Libtayo (cemiplimab) as adjuvant...
Acotec’s Jingyi Balloon Catheter Wins NMPA Approval for Complex Coronary Lesions
Acotec Scientific Holdings Limited (HKG: 6669) announced that China’s National Medical Products Administration (NMPA) has...
Roche’s Lunsumio SC Wins EU Conditional Approval for Follicular Lymphoma
Roche Holding AG (SWX: ROG, OTCMKTS: RHHBY) announced that the European Commission (EC) has granted...
PegBio’s PB‑119 (Paidakang) Wins NMPA Approval for Type 2 Diabetes Treatment
PegBio Co., Ltd. (HKG: 2565) announced that its next‑generation GLP‑1 receptor agonist PB‑119, marketed under...
Henlius’ POHERDY (HLX11) Receives Full FDA Approval for All Pertuzumab Indications
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its pertuzumab biosimilar POHERDY (clinical name HLX11)...
Gan & Lee’s Ondibta Receives Positive CHMP Opinion – EU Biosimilar Pathway Opened
Gan & Lee Pharmaceuticals Co., Ltd. (SHA: 603087) announced that the European Medicines Agency (EMA) has...