Truqap plus Faslodex approved in Japan for patients with advanced HR positive breast cancer

27 March 2024 - Approval based on CAPItello-291 results which showed Truqap plus Faslodex reduced the risk of disease progression ...

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Beyfortus approved in Japan for the prevention of RSV disease in infants

27 March 2024 - First and only RSV preventive option for broad infant population authorised for use in Japan. ...

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Takeda announces approval of Adzynma intravenous injection 1500 (apadamtase alfa/cinaxadamtase alfa) in Japan for patients with congenital thrombotic thrombocytopenic purpura

26 March 2024 - Adzynma (apadamtase alfa/cinaxadamtase alfa) is the first and only recombinant ADAMTS13 enzyme replacement therapy for people with congenital ...

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Astellas' Vyloy (zolbetuximab) approved in Japan for treatment of gastric cancer

26 March 2024 - MHLW approval makes Vyloy the first and only CLDN18.2-targeted therapy approved in the world. ...

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Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) granted priority review by Japan's Ministry of Health, Labour and Welfare for First-Line Treatment of Advanced Bladder Cancer

15 February 2024 - Priority review designation is based on results from the Phase 3 EV-302 trial, which found enfortumab vedotin ...

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Japan first in the world to approve Dupixent for chronic spontaneous urticaria

16 February 2024 - Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to ...

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Japan’s FY 2024 pricing reform expected to favour new listed innovative drugs

15 February 2024 - To address and maintain the financial sustainability of the national insurance system, the Government rolled out several ...

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Crovalimab approved in China as the first country for the treatment of paroxysmal nocturnal haemoglobinuria

8 February 2024 - Crovalimab, the fifth Chugai originated global drug, approved for the first time in the world. ...

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Eisai submits new drug application for mecobalamin ultra high dose formulation in Japan for the indication of amyotrophic lateral sclerosis

26 January 2024 - Eisai announced today that it has submitted a new drug application for ultra high dose mecobalamin (development ...

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Ezharmia supplemental new drug application submitted in Japan for patients with peripheral T-cell lymphoma

31 January 2024 - Submission for second indication of Sakigake designated Ezharmia based on VALENTINE-PTCL01 results in patients with relapsed ...

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First ever treatment for ultra rare rapid ageing disease progeria receives approval in Japan

20 January 2024 - The Progeria Research Foundation marks significant achievement as Zokinvy (lonafarnib) receives Japanese approval for the treatment ...

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Anti-epileptic drug Fycompa injection formulation approved in Japan

18 January 2024 - Eisai announced today that it has obtained marketing authorisation approval from the Japanese Ministry of Health, ...

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Halozyme announces argenx received approval in Japan for Vyvdura (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with Enhanze for generalised myasthenia gravis

18 January 2024 - Vyvdura provides patients with option for self-administration. ...

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Voydeya (danicopan) granted first ever regulatory approval in Japan for adults with PNH to be used in combination with C5 inhibitor therapy

19 January 2024 - Approval of first in class, oral, factor D inhibitor based on ALPHA Phase 3 trial in ...

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Bimzelx (bimekizumab) receives approval in Japan for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis

27 December 2023 - The extended approval for bimekizumab in Japan follows its first approval in January 2022 for plaque ...

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