Novavax announces approval of Nuvaxovid COVID-19 vaccine for primary and booster immunisation in Japan

19 April 2022 - Nuvaxovid is the first protein-based COVID-19 vaccine approved for use in adults aged 18 and older in ...

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Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for neovascular age-related macular degeneration and diabetic macular oedema

28 March 2022 - The bispecific antibody inhibits two disease pathways that drive nAMD and DME by blocking angiopoietin-2 (Ang-2) and ...

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Chugai obtains regulatory approval for Perjeta and Herceptin for additional indication of HER2 positive colorectal cancer

28 March 2022 - Combination therapy of Perjeta and Herceptin obtained regulatory approval for advanced or recurrent HER2 positive colon cancer ...

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Ono receives supplemental approval of Opdivo (nivolumab) for adjuvant treatment of urothelial carcinoma in Japan

28 March 2022 - Ono Pharmaceutical today announced that Ono has received a supplemental approval of Opdivo (nivolumab) in Japan for ...

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Tarlige tablets approved in Japan for treatment of patients with neuropathic pain

28 March 2022 - Daiichi Sankyo today announced that it has obtained approval in Japan to change the indication of ...

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Neurocrine Biosciences announces regulatory approval of Dysval (valbenazine) for the treatment of tardive dyskinesia in Japan

29 March 2022 - Neurocrine Biosciences today announced that its collaboration partner, Mitsubishi Tanabe Pharma Corporation, has obtained regulatory approval of ...

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Ondexxya approved in Japan for reversal of acute major bleeds in patients on factor Xa inhibitors

29 March 2022 - Ondexxya is the first approved reversal agent specifically for factor Xa inhibitors, providing a major advance ...

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Xenpozyme (olipudase alfa) approved in Japan, first and only approved therapy indicated to treat acid sphingomyelinase deficiency

28 March 2022 - Xenpozyme represents first Sanofi therapy to be approved under the SAKIGAKE ‘fast-track’ designation. ...

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Japan's Ministry of Health, Labour and Welfare accepts Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma

25 March 2022 - Bristol-Myers Squibb today announced that the MHLW has accepted the supplemental new drug application for Breyanzi ...

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Abbott's FreeStyle Libre is first and only CGM system to gain expanded reimbursement in Japan to include all people with diabetes who use insulin

24 March 2022 - Without expanded coverage, continuous glucose monitoring reimbursements are limited to segment of people with diabetes who require ...

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Submission of oral edarvarone formulation, MT-1186 new drug application in Japan for ALS

14 March 2022 - Mitsubishi Tanabe Pharma announced that the company has submitted to the MHLW in Japan an application ...

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Filing of humanised anti-CD20 monoclonal antibody Gazyva for additional indication of chronic lymphocytic leukaemia

7 March 2022 - Chugai files for regulatory approval following the results from the Phase 3 ELEVATE-TN trial evaluating Gazyva ...

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Eisai initiates submission of application data under the prior assessment consultation system in Japan with the aim of obtaining early approval for investigational anti-amyloid beta protofibril antibody lecanemab

4 March 2022 - Eisai and Biogen announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices ...

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Shionogi files for approval of S-217622, a therapeutic drug for COVID-19, in Japan

25 February 2022 - Shionogi today announced that Shionogi has completed the analysis of primary endpoints a), b) in the Phase ...

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Lenvima (lenvatinib) plus Keytruda (pembrolizumab) approved in Japan for radically unresectable or metastatic renal cell carcinoma

25 February 2022 - Results from CLEAR/KEYNOTE-581 showed Lenvima plus Keytruda significantly reduced the risk of disease progression or death by ...

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