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RSS FeedPosted by Michael Wonder on 25 Aug 2022
Tagrisso approved in Japan for the adjuvant treatment of patients with early-stage EGFR mutated lung cancer
25 August 2022 - Approval based on results from the ADAURA Phase 3 trial. ...
Posted by Michael Wonder on 25 Aug 2022
Lynparza approved in Japan as adjuvant treatment for patients with BRCA mutated HER2 negative high-risk early breast cancer
25 August 2022 - First and only approved medicine targeting BRCA mutations in early breast cancer ...
Posted by Michael Wonder on 16 Aug 2022
Chugai obtains regulatory approval for osteoporosis treatment Edirol
15 August 2022 - Chugai Pharmaceutical and Towa Pharmaceutical announced that Chugai obtained regulatory approval from the MHLW for an ...
Posted by Michael Wonder on 26 Jul 2022
Novavax announces expanded approval of Nuvaxovid COVID-19 vaccine for adolescents aged 12 through 17 in Japan
26 July 2022 - Nuvaxovid is the first protein-based COVID-19 vaccine approved for use in adolescents in Japan. ...
Posted by Michael Wonder on 27 Jun 2022
Trastuzumab deruxtecan supplemental new drug application submitted in Japan for patients with HER2 low metastatic breast cancer
27 June 2022 - Submission based on DESTINY-Breast04 results that showed trastuzumab deruxtecan demonstrated superior progression-free survival and overall survival ...
Posted by Michael Wonder on 22 Jun 2022
BioMarin announces the Ministry of Health, Labor and Welfare in Japan granted approval for Voxzogo (vosoritide) for injection for the treatment of children with achondroplasia, whose growth plates are not closed
21 June 2022 - No lower age restriction for treatment. ...
Posted by Michael Wonder on 07 Jun 2022
Japan drug maker tests medicine vending machine in train station
4 June 2022 - A Japanese pharmaceutical company has started a trial sale of cold medicine, painkillers and other drugs via ...
Posted by Michael Wonder on 16 May 2022
Japan pharma lobbies say pricing scheme leading to renewed 'drug lag'
16 May 2022 - Japan's three major pharmaceutical lobbies joined for the first time on Monday in urging reforms to ...
Posted by Michael Wonder on 19 Apr 2022
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 ...
Posted by Michael Wonder on 31 Mar 2022
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 ...
Posted by Michael Wonder on 31 Mar 2022
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 ...
Posted by Michael Wonder on 31 Mar 2022
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 ...
Posted by Michael Wonder on 29 Mar 2022
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 ...
Posted by Michael Wonder on 29 Mar 2022
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 ...
Posted by Michael Wonder on 29 Mar 2022
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 ...