Taiho Pharmaceutical obtains additional indication of "post-operative adjuvant chemotherapy for hormone receptor positive and HER2 negative breast cancer at high risk of recurrence" for oral anti-cancer agent TS-1

24 November 2022 - Based on POTENT study results. ...

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Enhertu approved in Japan for patients with previously treated HER2 positive metastatic breast cancer

24 November 2022 - Approval broadens indication for Enhertu to earlier use in metastatic breast cancer and requirement for confirmatory ...

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Ardelyx collaboration partner, Kyowa Kirin, announces submission of new drug application for tenapanor for hyperphosphataemia in Japan

31 October 2022 - Ardelyx today announced that its collaboration partner in Japan, Kyowa Kirin, has submitted a new drug application ...

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New reimbursement approved by the Japanese Ministry of Health, Labor and Welfare for the Accuray CyberKnife system to treat trigeminal neuralgia, a condition often causing severe facial pain

26 October 2022 - Accuray Incorporated announced today that the Japanese MHLW has approved reimbursement for the CyberKnife system for the ...

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CSL receives manufacturing and marketing authorisation in Japan for “Berinert SC injection 2000,” as a medicine for prevention of acute hereditary angioedema attacks

26 September 2022 - At home subcutaneous therapy advances treatment options for patients and marks a milestone in 40 years of ...

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Merck’s Keytruda (pembrolizumab) receives four new approvals in Japan, including in high risk early stage triple negative breast cancer

27 September 2022 - Keytruda now approved for 23 uses in 13 different types of cancer in Japan. ...

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Carvykti (ciltacabtagene autoleucel) receives approval from Japan’s MHLW for the treatment of patients with relapsed or refractory multiple myeloma

28 September 2022 - Legend Biotech announced today that Japan’s MHLW has approved Carvykti (ciltacabtagene autoleucel), a B-cell maturation antigen ...

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Koselugo approved in Japan for paediatric patients with plexiform neurofibromas in neurofibromatosis type 1

27 September 2022 - First medicine approved in Japan to treat this rare and debilitating genetic condition. ...

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Tezspire approved in Japan for the treatment of severe asthma

27 September 2022 - Tezspire approved for a broad population of patients with severe asthma with no phenotype or biomarker ...

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Fintepla (fenfluramine) approved in Japan for the treatment of seizures associated with Dravet syndrome

26 September 2022 - Nippon Shinyaku announced today that UCB Japan has obtained marketing approval from the Ministry of Health, ...

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Ezharmia approved in Japan as first dual EZH1 and EZH2 inhibitor therapy for patients with adult T-Cell leukaemia/lymphoma

26 September 2022 - Approval based on pivotal Phase 2 trial where Ezharmia demonstrated an objective response rate of 48% ...

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Japan health ministry panel backs Pfizer and Moderna omicron boosters

12 September 2022 - Pfizer and Moderna’s COVID-19 vaccines targeting the omicron variant have won the backing of health experts ...

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Amazon eyes Japan's online prescription drug market

5 September 2022 - E-commerce giant considers creating platform with local pharmacies. ...

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Recell System insurance coverage begins in Japan for treatment of acute burns

1 September 2022 - Reimbursement in Japan will be similar to that of pricing in the United States. ...

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Evusheld long-acting antibody combination approved for prevention and treatment of COVID-19 in Japan

30 August 2022 - First global approval for Evusheld as a COVID-19 treatment. ...

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