Keytruda (pembrolizumab) plus Lenvima (lenvatinib) approved in Japan for patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy

27 December 2021 - First approval in Japan for the Keytruda plus Lenvima combination. ...

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Valemetostat new drug application submitted in Japan for treatment of patients with adult T-cell leukaemia/lymphoma

28 December 2021 - Submission of orphan drug designated valemetostat based on pivotal phase 2 trial in patients with relapsed/refractory adult T-cell ...

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Japan’s First Committee on New Drugs of The Pharmaceutical Affairs and Food Sanitation Council seeks additional data; aducanumab remains under review

22 December 2021 - Biogen and Eisai today announced that the First Committee on New Drugs of the Pharmaceutical Affairs ...

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Merck and Ridgeback’s molnupiravir, an investigational oral anti-viral COVID-19 treatment, receives special approval for emergency in Japan

24 December 2021 - Molnupiravir, first oral COVID-19 antiviral medicine to receive authorisation in the world, now authorised in U.S., U.K. ...

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Novavax announces submission of new drug application in Japan for approval of COVID-19 vaccine

15 December 2021 - Takeda submits application for TAK-019/NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for new drug application, to Japan's ...

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Trastuzumab deruxtecan supplemental new drug application submitted in Japan for treatment of patients with HER2 positive metastatic breast cancer

14 December 2021 - Submission based on groundbreaking DESTINY-Breast03 phase 3 trial, in which trastuzumab deruxtecan demonstrated a 72% reduction in ...

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Huyabio International receives regulatory approval for Hiyasta monotherapy of peripheral T-cell lymphoma In Japan

30 November 2021 - This is the second indication for Hiyasta in Japan following adult T-cell leukaemia/lymphoma. ...

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Merck’s Keytruda (pembrolizumab) approved in Japan in combination with chemotherapy for first-line treatment of patients with radically unresectable, advanced or recurrent oesophageal carcinoma

30 November 2021 - Keytruda is now approved for 16 indications in Japan. ...

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Anti-cancer agent Herceptin approved for additional indication of salivary gland cancer

25 November 2021 - Herceptin has been approved as the first drug for salivary gland cancer, for which there is no ...

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Ono receives approval of Opdivo (nivolumab) for expanded use for two indications in Japan

25 November 2021 - Ono Pharmaceutical and Bristol-Myers Squibb today announced that Ono has received the approvals of Opdivo (nivolumab) for ...

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Merck and Ridgeback announce Japanese Government to purchase 1.6 million courses of molnupiravir, an investigational oral COVID-19 anti-viral medicine, upon authorisation or approval

10 November 2021 - Merck and Ridgeback Biotherapeutics today announced that the Japanese government will purchase, upon authorization or approval, approximately ...

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Japan’s MHLW approves Pfizer’s Cibinqo (abrocitinib) for adults and adolescents with moderate to severe atopic dermatitis

1 October 2021 - Pfizer today announced that the Japanese Ministry of Health, Labour and Welfare has approved Cibinqo (abrocitinib), ...

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Saphnelo approved in Japan for systemic lupus erythematosus

28 September 2021 - Saphnelo is a first in class type I interferon receptor antibody shown to reduce overall disease ...

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Fully human anti-TNF alfa monoclonal antibody Humira obtains additional approval for high dose regimen of ulcerative colitis in adult patients and for new regimen in paediatric patients

27 September 2021 - Eisai and EA Pharma announced today the additional approval for a high dose regimen in adult ...

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VFMCRP announces approval for Tavneos (avacopan) for the treatment of ANCA associated vasculitis in Japan

27 September 2021 - Partner Kissei to market Tavneos in Japan, with launch expected as soon as possible following National Health ...

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