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Boston Scientific’s Next-Gen IVUS System AVVIGO+ Approved by China’s NMPA for Coronary Disease Use
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US-based Boston Scientific Corporation (NYSE: BSX) has announced that China’s National Medical Products Administration (NMPA) has granted approval for its next-generation intravascular ultrasound (IVUS) diagnostic system, AVVIGO+, for use in diagnosing coronary heart disease. This marks a significant advancement in the diagnostic capabilities for cardiovascular healthcare in China. Multimodal Platform…
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DaAn Gene Co., Ltd Receives NMPA Approval for Genetic Deafness Gene Detection Kit
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China-based DaAn Gene Co., Ltd, (SHE: 002030) affiliated with Sun Yat-sen University, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its genetic deafness gene detection kit, which employs PCR flow cytometry fluorescence hybridization methodology. Advanced Technology for Genetic…
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FDA Approves Xcovery Holdings’ Ensartinib for Untreated ALK-Positive NSCLC Patients
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On December 18, 2024, the Food and Drug Administration (FDA) granted approval for Betta Pharmaceutical (SHE: 300558) and its controlling subsidiary Xcovery Holdings, Inc.’s ensartinib (Ensacove), a treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received…
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MicroPort CardioFlow Medtech’s VitaFlow Liberty Flex Receives NMPA Approval
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a prominent player in the medical device industry in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its third-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty Flex. This marks a significant advancement in…
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Lepu Scientech’s ScienCcrown TAVR System Earns NMPA Medical Device License
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Lepu Scientech Medical Technology (Shanghai) Co., Ltd (HKG: 2291), a leading China-based medical technology company, has announced that it has received a medical device license from the National Medical Products Administration (NMPA) for its innovative ScienCcrown transcatheter implantable aortic valve system. This development marks a significant milestone in the advancement…
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Eli Lilly’s Kisunla Receives NMPA Approval for Early Alzheimer’s Disease Treatment
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Eli Lilly and Company (NYSE: LLY), a leading pharmaceutical corporation in the US, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug donanemab-azbt, marketed under the name Kisunla. The drug is administered as a 350 mg/20 mL injection every four weeks…
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MicroPort CardioFlow’s VitaFlow Liberty Receives Marketing Approval in Turkey
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China-based MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) has announced that its second-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty, has received marketing approval from the Turkish Medicines and Medical Devices Agency (TITCK). This marks another global milestone for the product, following its approval in multiple countries and regions,…
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Roche’s cobas 6800/8800 Systems 2.0 Earn CE Certification, Set for US Market Entry
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Global healthcare company Roche (SWX: ROG) has announced that its state-of-the-art cobas 6800/8800 Systems 2.0 has received CE certification. This marks a significant advancement in the Swiss company’s polymerase chain reaction (PCR) technology. Optimizing Laboratory Efficiency with cobas 6800/8800 Systems 2.0The new cobas 6800/8800 Systems 2.0 update represents a major…
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Novo Nordisk’s Ozempic Receives Positive CHMP Opinion for Kidney Disease Indication
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Danish pharmaceutical leader Novo Nordisk (NYSE: NVO) has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on its label extension bid for Ozempic (once-weekly subcutaneous semaglutide). The company is seeking to expand the indication of the GLP-1 receptor…
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Johnson & Johnson MedTech’s Impella Heart Pumps Gain FDA Approval for Pediatric Heart Failure
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US major Johnson & Johnson MedTechhas announced receiving premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps. This approval expands their indications to include specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and…
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Grand Pharmaceutical Group Receives NMPA Approval for NOVASYNC HYBRID SYSTM
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China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative intravascular dual-mode imaging system, NOVASYNC HYBRID SYSTM. Milestone in Vascular Intervention TechnologyNOVASYNC, a domestic substitute for Grand Pharma’s imported NOVASIGHT HYBRID SYSTEM, signifies a…
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Huadong Medicine’s Arcalyst Receives NMPA Approval for Recurrent Pericarditis Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Arcalyst (rilonacept), a treatment for recurrent pericarditis (RP). This marks an expansion of the drug’s application in addressing autoimmune diseases. Rilonacept’s Mechanism and Global ApprovalsRilonacept is a recombinant…
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Sperogenix Therapeutics’ Agamree Receives NMPA Approval for Duchenne Muscular Dystrophy Treatment
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China-based rare disease specialist Sperogenix Therapeutics Limited has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Agamree (vamorolone), which is used to treat patients with Duchenne muscular dystrophy (DMD). This marks a significant milestone as Agamree becomes the first DMD drug approved in China,…
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Merck’s PD-1 Inhibitor Keytruda Approved by NMPA for Cervical Cancer Treatment in China
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its PD-1 inhibitor Keytruda (pembrolizumab). The approval allows the use of Keytruda in combination with chemotherapy for International Federation of Obstetrics and Gynecology (FIGO) 2014 stage III-IVA cervical…
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MSD’s Noxafil Receives NMPA Approval for Pediatric Use in Antifungal Treatment
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US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that China’s National Medical Products Administration (NMPA) has approved an extended indication for its antifungal agent Noxafil (posaconazole) to include pediatric patients in the prevention and treatment of fungal infections. This approval covers two dosage forms: enteric-coated tablets and…
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NMPA Approves Zynlonta for Relapsed or Refractory Large B-Cell Lymphoma Treatment
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The website of China’s National Medical Products Administration (NMPA) has indicated that the marketing filing for Zynlonta (loncastuximab tesirine), a collaboration between China’s Overland Pharmaceuticals and Swiss firm ADC Therapeutics SA (NYSE: ADCT), has been approved. This approval allows the CD19-targeted antibody-drug conjugate (ADC) to be used for treating adult…
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Stereotaxis and MicroPort EP Receive NMPA Approval for Magbot Magnetic Navigation Ablation Catheter
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US-based Stereotaxis, Inc. (NYSEAMERICAN: STXS) and its Chinese partner Shanghai MicroPort EP Medtech Co., Ltd. (SHA: 688351, MicroPort EP) have jointly announced the receipt of marketing approval from the National Medical Products Administration (NMPA) of China for their co-developed Magbot magnetic navigation ablation catheter. This approval marks a significant milestone…
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Eisai’s Urece (Dotinurad) Approved by China’s NMPA for Gout Treatment with Hyperuricemia
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Eisai’s (TYO: 4523) China unit has announced that it has received marketing approval from the National Medical Products Administration (NMPA) of China for its Urece (dotinurad), a uric acid excretion promoting drug. This approval allows the use of Urece to treat gout patients with hyperuricemia in China. Phase III Study…
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Lee’s Pharmaceutical Receives NMPA Approval for Generic Glaucoma Treatments
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic versions of Pfizer’s Xalatan (latanoprost), Novartis/ Alcon’s Travatan (travoprost), and Novartis/ Alcon’s Duotrav (travoprost, timolol). All three generic drugs…
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MicroPort Scientific Corp. Launches FireFalcon Balloon for Coronary Interventions with NMPA Approval
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Shanghai-based medical device giant MicroPort Scientific Corp., (HKG: 0853) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its FireFalcon coronary spinous process balloon, a novel device designed to enhance vascular dilation in coronary intervention therapy. Challenges of Traditional Balloon Dilation TechniquesBalloon dilation…
