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RSS FeedPosted by Michael Wonder on 19 Jan 2024
Voydeya (danicopan) granted first ever regulatory approval in Japan for adults with PNH to be used in combination with C5 inhibitor therapy
19 January 2024 - Approval of first in class, oral, factor D inhibitor based on ALPHA Phase 3 trial in ...
Posted by Michael Wonder on 27 Dec 2023
Bimzelx (bimekizumab) receives approval in Japan for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis
27 December 2023 - The extended approval for bimekizumab in Japan follows its first approval in January 2022 for plaque ...
Posted by Michael Wonder on 19 Dec 2023
Catalyst Pharmaceuticals announces Firdapse new drug application submitted in Japan by partner DyDo Pharma
18 December 2023 - Catalyst Pharmaceuticals today announced that its collaboration partner, DyDo Pharma reported that it has submitted a new ...
Posted by Michael Wonder on 13 Dec 2023
Japan’s Ministry of Health, Labour and Welfare accepts Arexvy (RSV vaccine) regulatory application to prevent RSV disease in adults aged 50-59 at increased risk
12 December 2023 - Submission supported by positive results of a Phase 3 study showing immune response and safety in adults ...
Posted by Michael Wonder on 07 Dec 2023
Bristol Myers Squibb's Abecma becomes first CAR T approved for use in earlier lines of therapy for patients with relapsed or refractory multiple myeloma in Japan
6 December 2023 - BMS announced today that the company has received manufacturing and marketing approval of the supplemental new ...
Posted by Michael Wonder on 29 Nov 2023
Japan's Ministry of Health, Labour and Welfare approves CSL and Arcturus Therapeutics' ARCT-154, the first self-amplifying mRNA vaccine approved for COVID in adults
27 November 2023 - Exclusive Partner in Japan, Meiji Seika Pharma advances regulatory approval. ...
Posted by Michael Wonder on 28 Nov 2023
Daichirona for intramuscular injection for booster vaccination approved in Japan as Omicron XBB.1.5 adapted monovalent mRNA vaccine against COVID-19
28 November 2023 - - Daiichi Sankyo today announced that Daichirona for intramuscular injection (DS-5670) for booster vaccination has been ...
Posted by Michael Wonder on 27 Nov 2023
ONO receives supplemental approval of Opdivo in Japan for expanded use for treatment of malignant mesothelioma (excluding malignant pleural mesothelioma)
24 November 2023 - Ono Pharmaceutical today announced that ONO has received supplemental approval of Opdivo (nivolumab) intravenous infusion, a ...
Posted by Michael Wonder on 27 Sep 2023
Japanese regulator OKs Celltrion's Humira biosimilar
26 September 2023 - Celltrion said it has received marketing approval from the Japanese Ministry of Health, Labor, and Welfare ...
Posted by Michael Wonder on 26 Sep 2023
Cara Therapeutics announces approval of Korsuva IV injection syringe in Japan for the treatment of pruritus in haemodialysis patients
25 September 2023 - Approval triggers $1.5 million milestone payment to Cara. ...
Posted by Michael Wonder on 26 Sep 2023
Takeda announces approval of Cuvitru subcutaneous immunoglobulin in Japan for patients with agammaglobulinaemia or hypogammaglobulinaemia
25 September 2023 - Approval is based on clinical studies conducted in Japan, Europe and North America confirming the ffficacy and ...
Posted by Michael Wonder on 25 Sep 2023
Leqembi intravenous infusion (lecanemab) approved for the treatment of Alzheimer’s disease in Japan
25 September 2023 - Eisai and Biogen announced today that humanised anti-soluble aggregated amyloid-beta monoclonal antibody “Leqembi intravenous infusion” (200 mg, ...
Posted by Michael Wonder on 25 Sep 2023
UCB announces approval of Rystiggo (rozanolixizumab) and Zilbryso (zilucoplan) for the treatment of adult patients with generalised myasthenia gravis in Japan
25 September 2023 - Approvals are based on pivotal phase 3 data for both medicines, showing statistical and clinically relevant improvements ...
Posted 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 ...