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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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, ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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