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RSS FeedPosted by Michael Wonder on 08 Sep 2023
Omicron XBB.1.5 adapted COVID-19 vaccine (DS-5670) supplemental new drug application submitted in Japan
7 September 2023 - – Daiichi Sankyo today announced that it has submitted a supplemental New Drug Application to Japan’s ...
Posted by Michael Wonder on 24 Aug 2023
Soliris approved in Japan for paediatric patients with generalised myasthenia gravis
24 August 2023 - Soliris reduced disease severity and symptoms with sustained improvements over 26 weeks in Phase III clinical ...
Posted by Michael Wonder on 23 Aug 2023
Enhertu approved in Japan as first HER2 directed therapy for patients with HER2 mutant metastatic non-small-cell lung cancer
23 August 2023 - Approval based on DESTINY-Lung02 results showing Enhertu demonstrated a clinically meaningful tumour response of 53.8% in ...
Posted by Michael Wonder on 26 Jun 2023
Japan’s Ministry of Health, Labour and Welfare approves Shingrix for the prevention of shingles in at-risk adults aged 18 and over
26 June 2023 - Shingrix (recombinant zoster vaccine) is already approved in Japan for adults aged 50 and over. ...
Posted by Michael Wonder on 09 Jun 2023
Astellas submits new drug application for zolbetuximab in Japan
9 June 2023 - Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced ...
Posted by Michael Wonder on 29 May 2023
Ultomiris approved in Japan for the prevention of relapses in patients with neuromyelitis optica spectrum disorder
26 May 2023 - Ultomiris has the potential to eliminate relapses and redefine the treatment landscape for anti-aquaporin-4 (AQP4) antibody positive neuromyelitis ...
Posted by Michael Wonder on 29 Mar 2023
Takeda receives approval to manufacture and market Entyvio subcutaneous injection in Japan for the maintenance treatment of moderate to severe ulcerative colitis
27 March 2023 - Subcutaneous administration provides a new treatment option for patients with ulcerative colitis who have had an ...
Posted by Michael Wonder on 28 Mar 2023
Ono receives supplemental approval of Opdivo in combination with chemotherapy for neo-adjuvant treatment of non-small-cell lung cancer in Japan
27 March 2023 - Ono Pharmaceutical and Bristol-Myers Squibb today announced that Ono Pharmaceutical has received a supplemental approval of ...
Posted by Michael Wonder on 27 Mar 2023
Incyte announces Japanese approval of Pemazyre (pemigatinib) for the treatment of patients with myeloid/lymphoid neoplasms
27 March 2023 - Incyte today announced that the Japanese Ministry of Health, Labour and Welfare has approved Pemazyre (pemigatinib), a ...
Posted by Michael Wonder on 27 Mar 2023
Enhertu approved in Japan as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
27 March 2023 - Approval based on DESTINY-Breast04 results showing Enhertu reduced the risk of disease progression or death by ...
Posted by Michael Wonder on 09 Mar 2023
Mallinckrodt announces reimbursement approval in Japan for the Celllex extracorporeal photopheresis system for the treatment of chronic graft versus host disease
9 March 2023 - Cellex ECP is now available for reimbursement in Japan for patients who are steroid-resistant or intolerant ...
Posted by Michael Wonder on 03 Mar 2023
Bayer submits aflibercept 8 mg for marketing authorisation in Japan
1 March 2023 - Submission to the MHLW in Japan for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) ...
Posted by Michael Wonder on 28 Feb 2023
Darolutamide receives approval for additional prostate cancer indication in Japan
27 February 2023 - New approval is based on data from the pivotal Phase 3 ARASENS trial. ...
Posted by Michael Wonder on 30 Jan 2023
Lecanemab receives priority review status in Japan
29 January 2023 - Eisai and Biogen announced today that an application for manufacturing and marketing approval for lecanemab, an anti-amyloid-β ...
Posted by Michael Wonder on 13 Jan 2023
Daiichi Sankyo submits application for marketing approval of mRNA COVID-19 vaccine (DS-5670) in Japan
13 January 2023 - Daiichi Sankyo today announced the submission of an application for marketing approval of DS-5670 to the ...