J&J Darzalex Faspro Gets FDA Nod for NDMM D-VRd Regimen
Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved...
Product approvals
Leqvio Gets NMPA Nod for Monotherapy in China Hypercholesterolemia
Novartis (NYSE: NVS) announced that Leqvio (inclisiran) has received an additional indication approval from the National...
Bio-heart Secures Indonesia Approval for Iberis RDN System
Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced market approval in Indonesia for its...
Visen Pharma Secures NMPA Approval for Skytrofa in Pediatric Growth Hormone Deficiency
Visen Pharmaceuticals (HKG: 2561), a joint venture between Ascendis Pharma (Denmark) and Vivo Capital, announced...
MicroPort Endovascular’s Talos Stent Graft Secures EU CE MDR Certification
Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) announced that its Talos straight thoracic aortic...
Huahui Health’s Libevitug Wins NMPA Approval as World’s First HDV Antibody Therapy
Huahui Health announced that China’s National Medical Products Administration (NMPA) has granted conditional approval for...
AstraZeneca’s Soliris Wins NMPA Approval for Pediatric Myasthenia Gravis
AstraZeneca plc (AZ, NASDAQ: AZN) announced that China’s National Medical Products Administration (NMPA) has approved Soliris...
AbbVie Secures Second China Approval for Risankizumab in Ulcerative Colitis
AbbVie Inc. (NYSE: ABBV) announced that China’s National Medical Products Administration (NMPA) has approved Risankizumab (SKYRIZI)...
Enhertu Wins China NMPA Approval for Second‑Line HER2‑Positive Gastric Cancer
AstraZeneca plc (AZ, NASDAQ: AZN) and Daiichi Sankyo Company, Limited (TYO: 4568) announced that Enhertu (trastuzumab deruxtecan)...
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...
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...