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RSS FeedPosted by Michael Wonder on 08 Feb 2024
Crovalimab approved in China as the first country for the treatment of paroxysmal nocturnal haemoglobinuria
8 February 2024 - Crovalimab, the fifth Chugai originated global drug, approved for the first time in the world. ...
Posted by Michael Wonder on 01 Feb 2024
Eisai submits new drug application for mecobalamin ultra high dose formulation in Japan for the indication of amyotrophic lateral sclerosis
26 January 2024 - Eisai announced today that it has submitted a new drug application for ultra high dose mecobalamin (development ...
Posted by Michael Wonder on 31 Jan 2024
Ezharmia supplemental new drug application submitted in Japan for patients with peripheral T-cell lymphoma
31 January 2024 - Submission for second indication of Sakigake designated Ezharmia based on VALENTINE-PTCL01 results in patients with relapsed ...
Posted by Michael Wonder on 21 Jan 2024
First ever treatment for ultra rare rapid ageing disease progeria receives approval in Japan
20 January 2024 - The Progeria Research Foundation marks significant achievement as Zokinvy (lonafarnib) receives Japanese approval for the treatment ...
Posted by Michael Wonder on 19 Jan 2024
Anti-epileptic drug Fycompa injection formulation approved in Japan
18 January 2024 - Eisai announced today that it has obtained marketing authorisation approval from the Japanese Ministry of Health, ...
Posted by Michael Wonder on 19 Jan 2024
Halozyme announces argenx received approval in Japan for Vyvdura (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with Enhanze for generalised myasthenia gravis
18 January 2024 - Vyvdura provides patients with option for self-administration. ...
Posted 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 ...