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RSS FeedPosted by Michael Wonder on 28 Nov 2021
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 ...
Posted by Michael Wonder on 27 Nov 2021
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 ...
Posted by Michael Wonder on 10 Nov 2021
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 ...
Posted by Michael Wonder on 01 Oct 2021
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), ...
Posted by Michael Wonder on 28 Sep 2021
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 ...
Posted by Michael Wonder on 28 Sep 2021
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 ...
Posted by Michael Wonder on 28 Sep 2021
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 ...
Posted by Michael Wonder on 22 Sep 2021
Pharmaceuticals and Medical Devices Agency's horizon scanning and the Science Board: co-operation toward extracellular vesicle-based products
15 September 2021 - In addition to support academia with regulatory scientific advice, the Pharmaceuticals and Medical Devices Agency' is proactively ...
Posted by Michael Wonder on 28 Aug 2021
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, ...
Posted by Michael Wonder on 26 Aug 2021
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 ...
Posted by Michael Wonder on 25 Aug 2021
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 ...
Posted by Michael Wonder on 18 Aug 2021
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 ...
Posted by Michael Wonder on 09 Aug 2021
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 ...
Posted by Michael Wonder on 20 Jul 2021
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 ...
Posted by Michael Wonder on 04 Jul 2021
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. ...