AstraZeneca Secures NMPA Approval for Fasenra in EGPA, Demonstrating Superior Steroid-Sparing Effect
AstraZeneca PLC (AZ, NASDAQ: AZN) announced that Fasenra (benralizumab) has received additional approval from China’s...
Product approvals
Innovent Biologics Secures NMPA Approval for TABOSUN as First Neoadjuvant Dual‑IO Therapy for MSI‑H/dMMR Colon Cancer
Innovent Biologics, Inc. (HKG: 1801) announced that China’s National Medical Products Administration (NMPA) has approved...
Wantai Biological Secures NMPA Approval for First Oral HIV Self-Test Kit in China
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. (SHA: 603392) announced that its Human Immunodeficiency Virus...
UniPath Bronchoscopic Robot Wins NMPA Approval, Expanding MedBot’s Surgical Portfolio
Shanghai MicroPort MedBot (Group) Co., Ltd. (HKG: 2252) announced that its self‑developed UniPath Electronic Bronchoscopic...
Novo Nordisk’s Sogroya Wins NMPA Approval for Pediatric Growth Hormone Deficiency
Novo Nordisk (NYSE: NVO) announced that its once‑weekly long‑acting growth hormone (LAGH) injection, Sogroya (somapacitan), received...
J&J’s Amivantamab Subcutaneous Wins China Approval for NSCLC
Johnson & Johnson (J&J, NYSE: JNJ) announced that its Amivantamab Injection (Subcutaneous), marketed as RYBREVANT, received...
Novo Nordisk’s Wegovy Wins China Cardiovascular Approval in Weight-Loss Market Expansion
Novo Nordisk (NYSE: NVO) announced that China’s National Medical Products Administration (NMPA) approved Wegovy (semaglutide)...
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)...
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...