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...
Product approvals
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...
Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Wins New NMPA Approval for NSCLC
China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced receiving another indication approval from the...
Hansoh Pharmaceutical’s Ameile Wins New NMPA Approval for Advanced NSCLC Treatment
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced receiving another indication approval from the...
Jiangsu Cowin Biotech Obtains NMPA License for Gene Methylation Detection Kit
China-based Jiangsu Cowin Biotech Co., Ltd. (SHA: 688426) announced receiving a Category III medical device...
Bristol-Myers Squibb’s Opdivo/Yervoy Combo Approved by EU for Hepatocellular Carcinoma
US giant Bristol-Myers Squibb (BMS, NYSE: BMY) announced receiving marketing approval from the European Commission...