Aosaikang’s Delafloxacin Wins NMPA Approval as First Fluoroquinolone for China Infections
Beijing Aosaikang Pharmaceutical Co., Ltd. (SHE: 002755) announced that China’s National Medical Products Administration (NMPA)...
Product approvals
3SBio’s rhTPO Wins NMPA Approval for Liver Disease Thrombocytopenia Before Surgery
3SBio Inc. (HKG: 1530) announced that its Recombinant Human Thrombopoietin (rhTPO) injection received National Medical...
J&J TREMFYA Pediatric Psoriasis EC Approval Targets First IL-23 Indication
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has extended the...
Merck’s Pimicotinib Wins China Approval as First Class 1 Therapy for TGCT
Merck KGaA (ETR: MRK) announced that China’s National Medical Products Administration (NMPA) granted priority review approval...
GSK’s Nucala Wins China Approval as First IL‑5 Biologic for COPD
GlaxoSmithKline (GSK, NYSE: GSK) China announced that China’s National Medical Products Administration (NMPA) approved Nucala...
Antengene Xpovio sNDA Malaysia Approval Expands DLBCL Indication
Antengene Corporation Limited (HKG: 6996) announced that the Malaysian National Pharmaceutical Regulatory Agency has approved...
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)...