Merck’s Keytruda (pembrolizumab) receives two new approvals in Japan

26 August 2021 - Keytruda now approved for the treatment of patients with PD-L1 positive, hormone receptor negative and HER2 negative, ...

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Forxiga approved in Japan for the treatment of chronic kidney disease in patients with and without type 2 diabetes

26 August 2021 - Approval marks an important transformation in the treatment of more than 13 million people suffering from ...

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Ono and Takeda receive an approval for Opdivo (nivolumab) and Cabometyx (cabozantinib) combination therapy in Japan for treatment of unresectable or metastatic renal cell carcinoma

25 August 2021 - Ono Pharmaceutical and Takeda today announced that the companies have received an approval for combination therapy of ...

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AmoyDx Pan lung cancer PCR panel receives MHLW approval as companion diagnostic for Tepmetko (tepotinib)

17 August 2021 - Riken Genesis, Amoy Diagnostics and Precision Medicine Asia today announced that the Ministry of Health, Labour ...

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Japan drug maker Shionogi to seek approval for oral COVID-19 drug

6 August 2021 - Pharmaceutical firm Shionogi plans to seek state approval for its oral coronavirus drug by the end ...

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Japan becomes first country to approve Regeneron antibody cocktail (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

20 July 2021 - Regeneron Pharmaceuticals today announced that Japan's Ministry of Health, Labour and Welfare has approved Regeneron's casirivimab and ...

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Solasia announces submission of new drug application for anti-cancer drug darinaparsin for peripheral T-cell lymphoma in Japan

30 June 2021 - New drug application filed in Japan ahead of anywhere else in the world. ...

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Vericiguat approved in Japan to treat patients with chronic heart failure

23 June 2021 - Heart failure affects approximately 1.2 million people in Japan. ...

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Evrysdi approved in Japan for the treatment of spinal muscular atrophy

23 June 2021 - 48th country that approved Evrysdi. ...

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Teva announces Ministry of Health, Labour and Welfare approves Ajovy (fremanezumab) injection in Japan for the preventive treatment of migraine in adults

23 June 2021 - Ajovy developed by Otsuka in Japan through exclusive license agreement. ...

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Anticancer agent Tazverik 200 mg tablets (tazemetostat hydrobromide) approved in Japan for EZH2 gene mutation positive follicular lymphoma

23 June 2021 - Eisai announced today that it has obtained manufacturing and marketing approval for the EZH2 inhibitor Tazverik ...

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Delytact oncolytic virus G47∆ approved in Japan for treatment of patients with malignant glioma

10 June 2021 - First oncolytic virus ever approved for treatment of malignant glioma or any primary brain cancer. ...

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Marketing approval received in Japan for Ninlaro as a maintenance therapy after first-line treatment for multiple myeloma without prior stem cell transplantation

27 May 2021 - Takeda today announced that it has received approval from the Japanese Ministry of Health, Labour and ...

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Japan issues final approval for Moderna and AstraZeneca vaccines

21 May 2021 - Health minister Norihisa Tamura gave his final approval Friday for emergency use of two more COVID-19 ...

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Japan’s Ministry of Health, Labour and Welfare grants priority review for enfortumab vedotin new drug application

14 May 2021 - New drug application, submitted in March, is for locally advanced or metastatic urothelial cancer that has ...

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