The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Takeda Pharmaceutical's new drug application (NDA) of Adcetris (brentuximab vedotin) 50mg intended to treat patients with CD30 positive relapsed or refractory hodgkin ...
Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that its collaborator, Takeda Pharmaceutical Company Limited (Takeda), has received approval of ADCETRIS (brentuximab vedotin) from the Japanese Ministry of Health, Labour and Welfare ...
Vascular Solutions, a medical device company, has obtained Shonin approvals from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its GuideLiner guide extension catheter and the SuperCross FT microcatheter. Japan Lifeline, ...
Tags: Vascular Solutions, medical device, MHLW, extension catheter
Asahi Kasei Zoll Medical, the Japanese subsidiary of Zoll Medical, has obtained Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its X Series monitor/defibrillator, designed primarily for emergency medical ...
Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Bayer HealthCare's Eylea (aflibercept, solution for intravitreal injection) for the treatment of macular edema secondary to central retinal vein occlusion (CRVO). In ...
Lumenis has obtained the US Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare (MHLW) approvals for its Array LaserLink pattern scanning device for multi-spot laser photocoagulation for use during ...
Tags: Lumenis, Laser Treatment
PLC Systems, a medical device company, has obtained an approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to initiate a single-arm clinical trial in Japan using its RenalGuard therapy. This approval is based on MHLW's ...
Tags: PLC Systems, Renalguard Therapy
Biotechnology firm Alexion Pharmaceuticals has secured approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the use of its Soliris (eculizumab) drug to treat pediatric and adult patients with atypical hemolytic ...
Tags: Ahus Treatment, Soliris Drug
Edwards Lifesciences has obtained the reimbursement for its Sapien XT transcatheter aortic valve implant from Japan's Central Social Insurance Medical Council (Chuikyo) after the recommendation made by the Japanese Ministry of Health, Labor ...
Tags: XT Valve, Edwards Lifesciences
Toa Eiyo has received manufacturing and marketing authorization for Bisono Tape 4mg and 8mg medicines (Bisono Tape) in Japan from the Japanese Ministry of Health, Labour and Welfare (MHLW). Developed by Nitto Denko in partnership with Toa ...
The Japanese Ministry of Health, Labour and Welfare (MHLW) has cleared Roche's Avastin (bevacizumab) as a combination therapy and monotherapy to treat the aggressive form of brain cancer glioblastoma. The first new medicine that is ...
Tags: Glioblastoma Therapy, Medicine
Zoll Medical has gained Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its intravascular temperature management (IVTM) system, designed for use in neurologically injured patients to control fever. The ...
Tags: Medical, care decices, clinical trial
Cosmotec, a distribution partner of Endologix in Japan, has obtained Shonin approval from Japanese Ministry of Health, Labor and Welfare (MHLW) for its IntuiTrak Delivery system. Featuring a simplified deployment mechanism and hydrophilic ...
Tags: Cosmotec, Endologix, Japan, Shonin approval, MHLW
Cytori Therapeutics has expanded its Celution system's CE mark approval to include several new indications including cryptoglandular fistula. The Celution system, which pulls stem cells and other regenerative cells out of fat , provides ...
Tags: Cytori Therapeutics, cryptoglandular fistula, celution system
Regeneron Pharmaceuticals has received Japanese Ministry of Health,Labour and Welfare(MHLW)approval for its Eylea(aflibercept)injection to treat patients with neovascular age-related macular degeneration(wet AMD)symptoms. Regeneron chief ...
Tags: Regeneron Pharmaceuticals, Eylea Injection, wet AMD, George Yancopoulos