Johnson & Johnson’s Tremfya Gains FDA Approval for Crohn’s Disease Treatment
US pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced receiving clearance from the...
Product approvals
Novartis’ Fabhalta Approved by FDA for C3 Glomerulopathy Treatment
Swiss pharmaceutical giant Novartis’ (NYSE: NVS) iptacopan, marketed as Fabhalta, has received approval from the...
Telix Pharmaceuticals Gains Brazilian Approval for Prostate Cancer Diagnostic Agent TLX591-CDx
Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) announced receiving clearance from the Brazilian Health Regulatory Agency...
AstraZeneca’s Imfinzi Approved in EU for Limited-Stage Small Cell Lung Cancer
UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has received approval from the European Union (EU) for...
Lifetech Scientific’s Aortic Stent System Approved by China’s NMPA
China-based Lifetech Scientific Corporation (HKG: 1302) announced receiving market approval from the National Medical Products...
ROBO Medical’s Innovative Gastrointestinal Endoscopic Instrument Gains NMPA Approval
China’s National Medical Products Administration (NMPA) has approved ROBO Medical’s gastrointestinal endoscopic surgical instrument control...
BMS’s Breyanzi Approved by EC for Relapsed or Refractory Follicular Lymphoma
US giant Bristol-Myers Squibb (BMS; NYSE: BMY) announced receiving another indication approval from the European...
Inari Medical Wins NMPA Approval for Thrombectomy Stent System in China
US-based Inari Medical, Inc. (NASDAQ: NARI), set to be acquired by Stryker (NYSE: SYK), announced...
Jiangsu Hengrui Pharmaceuticals’ Tegileridine Approved for Postoperative Pain Management
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving another indication approval from the...
MicroPort Endovascular MedTech’s Cratos System Approved for Aortic Dissection Treatment
Shanghai MicroPort Endovascular MedTech Co., Ltd’s (SHA: 688016) Cratos branched aortic stent graft system has...
Akeso Biopharma’s Penpulimab Approved for First-Line NPC Treatment
China-based Akeso Biopharma (HKG: 9926) announced receiving another indication approval from the National Medical Products...
Innovent Biologics’ Sycume Approved by China’s NMPA for Thyroid Eye Disease
China-based Innovent Biologics Inc. (HKG: 1801) announced that its New Drug Application (NDA) for Sycume...
Roche’s Itovebi Approved in China for PIK3CA-Mutated Breast Cancer
Itovebi (inavolisib), a best-in-class PI3Kα inhibitor from Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), has...
Gaush Meditech’s ANTERION Ophthalmic Detector Receives NMPA Market Approval
Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced receiving market approval from the National Medical Products...
Otsuka and Lundbeck Win EU Approval for Rxulti in Adolescent Schizophrenia
Japan-based Otsuka Pharmaceutical Co., Ltd and its Danish partner Lundbeck A/S (OTCMKTS: HLUBF) jointly announced...
Gaush Meditech Receives NMPA Approval for Femtosecond Laser Corneal Refractive Surgery System
Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced receiving market approval from the National Medical Products...
Johnson & Johnson MedTech Gains FDA Clearance for MONARCH QUEST with AI Algorithms
US major Johnson & Johnson MedTech announced receiving U.S. 510(k) regulatory clearance for its MONARCH...
Novartis’ Cosentyx Approved by NMPA for Moderate to Severe Hidradenitis Suppurativa
Swiss giant Novartis’ (NYSE: NVS) Cosentyx (secukinumab) has secured another indication approval from China’s National...
AstraZeneca’s Imfinzi Approved by NMPA for Early-Stage NSCLC Treatment
UK-based giant AstraZeneca (NASDAQ: AZN) received approval from China’s National Medical Products Administration (NMPA) for...
Huihe Healthcare’s K-Clip Wins Chinese Approval for Tricuspid Regurgitation Treatment
Shanghai-based Huihe Healthcare, a developer of structural heart disease intervention medical devices, announced receiving marketing...