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RSS FeedPosted by Michael Wonder on 26 Sep 2022
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, ...
Posted by Michael Wonder on 26 Sep 2022
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% ...
Posted by Michael Wonder on 12 Sep 2022
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 ...
Posted by Michael Wonder on 06 Sep 2022
Amazon eyes Japan's online prescription drug market
5 September 2022 - E-commerce giant considers creating platform with local pharmacies. ...
Posted by Michael Wonder on 01 Sep 2022
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. ...
Posted by Michael Wonder on 30 Aug 2022
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. ...
Posted by Michael Wonder on 30 Aug 2022
Quizartinib supplemental new drug application submitted in Japan for patients with newly diagnosed FLT3-ITD positive acute myeloid leukaemia
30 August 2022 - Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy ...
Posted by Michael Wonder on 25 Aug 2022
Myriad Genetics receives expanded coverage in Japan for use of BRACAnalysis Diagnostic System as a companion diagnostic for Lynparza in early-stage breast cancer
25 August 2022 - Myriad Genetics today announced Japan’s MHLW has granted expanded coverage for the use of Myriad’s BRACAnalysis ...
Posted by Michael Wonder on 25 Aug 2022
Ultomiris approved in Japan for the treatment of adults with generalised myasthenia gravis
25 August 2022 - First and only long-acting C5 complement inhibitor offers early onset and sustained efficacy, and has the ...
Posted by Michael Wonder on 25 Aug 2022
Chugai obtains regulatory approval for Polivy for additional indication of previously untreated diffuse large B-cell lymphoma
24 August 2022 - The approval is based on the results from a Phase 3 POLARIX study in patients with ...
Posted 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 ...