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...
Drug
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...
Akeso’s Cadonilimab Wins FDA Nod for Global Phase 3 Gastric Cancer Study
Akeso Biopharma (HKG: 9926) announced that the U.S. FDA approved cadonilimab in combination with chemotherapy...
Junshi Biosciences Wins FDA Nod for EGFR/HER3 Bispecific ADC in Solid Tumors
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) announced that the U.S. Food and...
Henlius Serplulimab NDA Wins Priority Review for Gastric Cancer as Adjuvant Therapy
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the NMPA accepted its New Drug Application...
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...
Huadao Submits China CAR‑T Application for Refractory Lymphoma in $1B Market
Suzhou Huadao Biological Pharmacy Co., Ltd. officially submitted a Marketing Authorization Application (MAA) to the...
Lilly’s Retatrutide Achieves 28.7% Weight Loss in Phase 3 Obesity-Osteoarthritis Trial
Eli Lilly & Co. (NYSE: LLY) announced positive topline results from the Phase 3 TRIUMPH‑4...
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...
Lobemilast (Y‑3) NDA Accepted by NMPA as First Multi‑Target Stroke Neuroprotectant
Neurodawn Pharmaceutical Co., Ltd. announced that its self‑developed Category 1 chemical drug, Y‑3 for Injection (generic...
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...
Innovent’s PECONDLE Meets Phase 3 IL‑23 Psoriasis Endpoints with Quarterly Dosing
Innovent Biologics, Inc. (HKG: 1801) announced that PECONDLE (picankibart injection, IBI112), its self‑developed anti‑IL‑23p19 monoclonal...
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...
Innovent Doses First Patient in Phase 1 Trial of IBI3011, China’s First Anti‑IL‑1RAP Antibody for Gout Flares
Innovent Biologics, Inc. (HKG: 1801) announced that the first participant has been dosed in a...
Shanghai Henlius Secures NMPA Approval for Phase II/III HLX22 HER2 Trials, Pioneering Novel Epitope ADC Combination in Breast Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
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...