AstraZeneca’s Imfinzi Wins China Approval for Endometrial Cancer, Securing Seventh Indication
AstraZeneca (AZ, NASDAQ: AZN) announced that Imfinzi (durvalumab) has been officially approved in China for use...
Product approvals
Abbott’s TactiFlex Duo Wins CE Mark for Atrial Fibrillation Treatment in Europe
Abbott (NYSE: ABT) announced it has received CE Mark approval in Europe for the TactiFlex Duo...
Blue Sail’s Lithonic IVL System Wins CE Mark for Coronary Calcified Lesions
Blue Sail Medical Co., Ltd (SHE: 002382) announced that its Lithonic coronary intravascular shockwave therapy...
Shionogi’s Fetroja Wins China NMPA Approval for Complicated UTIs, Targets Resistant Gram‑Negative Infections
Shionogi Co., Ltd announced that China’s National Medical Products Administration (NMPA) has granted marketing approval...
Biogen’s High‑Dose SPINRAZA Wins EU Approval for 5q SMA After Japan Nod
Biogen Inc. (NASDAQ: BIIB) announced that the European Commission (EC) has granted marketing authorization for a...
Gan & Lee’s Insulin Glargine Wins Ethiopia Approval, Challenging Sanofi’s Dominance
Gan & Lee Pharmaceuticals (SHA: 603087) announced that its insulin glargine injection and pre‑filled insulin...
Sanofi’s Teizeild Wins EU Approval as First Disease‑Modifying Therapy for Type 1 Diabetes
Sanofi (NASDAQ: SNY) announced that the European Commission has approved Teizeild (teplizumab), a CD3‑targeted monoclonal antibody,...
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...
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...