FDA Approves Zycubo as First Therapy for Pediatric Menkes Disease, Targeting Ultra‑Rare Copper Deficiency Disorder
The U.S. Food and Drug Administration (FDA) has approved Zycubo (copper histidinate) injection, the first...
Product approvals
Lifetech Scientific Secures NMPA Approval for G‑iliac Pro – Upgraded Iliac Branch Device for Aortic Aneurysm Repair
Lifetech Scientific Corporation (HKG: 1302) announced that China’s National Medical Products Administration (NMPA) has granted market...
Santen’s UPNEEQ Wins Japan Approval for Acquired Ptosis
Santen Pharmaceutical Co., Ltd. announced that UPNEEQ Mini 0.1% oxymetazoline solution (STN1013800) has been approved...
Shanghai Pharma Receives NMPA Approval for Myasthenia Gravis Oral Solution
Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) announced that its subsidiary, Shanghai SPH Zhongxi Pharmaceutical...
Boan Biosimilar Prolia Wins Bolivia Approval, Targets Global Markets
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that BA6101, its biosimilar version of Amgen’s...
Hansoh Pharmaceutical’s Ameile Wins Fifth NMPA Indication for EGFR‑Mutated NSCLC
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that its core product, Ameile (almonertinib), has...
Hengrui’s Retlirafusp α Wins NMPA Approval for First-Line Gastric Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that its self-developed Category 1 drug,...
Sanofi’s Redemplo Wins NMPA Approval as First siRNA for Familial Chylomicronemia
Sanofi (NASDAQ: SNY) announced that Redemplo (plozasiran sodium injection), the world’s first small interfering RNA...
Zai Lab’s Repotrectinib Wins NMPA sNDA for NTRK Fusion-Positive Solid Tumors
Zai Lab Ltd. (NASDAQ: ZLAB, HKG: 9688) announced that the supplemental New Drug Application (sNDA)...
BeOne’s Sonrotoclax Wins Conditional NMPA Approval for BCL-2 Inhibitor in CLL/SLL and MCL
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that its self‑developed Class 1 innovative drug...
Ark Biopharma’s Azstarys Approved in China for ADHD, First New Methylphenidate in 20 Years
Shanghai Ark Biopharmaceutical Co., Ltd. announced that Azstarys (serdexmethylphenidate, dexmethylphenidate) has been approved by China’s...
Merck’s Winrevair Wins China NMPA Approval for Pulmonary Arterial Hypertension
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that Winrevair (sotatercept for injection), the world’s...
AstraZeneca and Ionis’ Eplontersen Wins China Approval for ATTRv-PN as First Gene-Silencing Therapy
AstraZeneca PLC (AZ, NASDAQ: AZN) and Ionis Pharmaceuticals (NASDAQ: IONS) announced that Wainua (eplontersen) has received approval...
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...
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)...