Antengene Xpovio sNDA Malaysia Approval Expands DLBCL Indication
Antengene Corporation Limited (HKG: 6996) announced that the Malaysian National Pharmaceutical Regulatory Agency has approved...
Product approvals
Everest lerodalcibep PCSK9 FDA Approval Targets China Launch
Everest Medicines Limited (HKG: 1952) announced that the U.S. FDA has approved the Biologics License...
Cryofocus GERD System Secures NMPA Approval in China
Cryofocus Medtech (Shanghai) Co., Ltd. (HKG: 6922) announced that its Anti-Gastroesophageal Reflux System has been...
GSK’s Exdensur Wins FDA Approval as First Twice‑Yearly Asthma Biologic
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) approved...
Aficamten Wins China Approval as HCM Drug in Global First for Sanofi
Sanofi (NASDAQ: SNY) announced that aficamten, a second‑generation cardiac myosin inhibitor, received marketing approval from...
ENHERTU Wins FDA Approval as First-Line HER2 Breast Cancer Therapy
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) announced that ENHERTU (fam-trastuzumab deruxtecan-nxki) in...
GSK’s Nucala Wins CHMP Nod for COPD in Europe
UK biopharma GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the European Medicines Agency’s Committee for...
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...
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...
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...
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...
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...