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RSS FeedPosted by Michael Wonder on 24 Mar 2026
Dupixent (dupilumab) approved in Japan as the first targeted medicine to treat adults with bullous pemphigoid
24 March 2026 - Bullous pemphigoid is the seventh approved indication for Dupixent in Japan ...
Posted by Michael Wonder on 23 Mar 2026
Enhertu now available in Japan as first antibody drug conjugate for the second-line treatment of patients with HER2 positive metastatic gastric cancer
23 March 2026 - Based on DESTINY-Gastric04 Phase 3 trial results that showed Enhertu demonstrated statistically significant and clinically meaningful ...
Posted by Michael Wonder on 23 Mar 2026
Enhertu approved in Japan as first tumour agnostic HER2 directed medicine for previously treated patients with HER2 positive metastatic solid tumours
23 March 2026 - Based on four Phase 2 trials where Enhertu demonstrated clinically meaningful responses across a broad range ...
Posted by Michael Wonder on 27 Feb 2026
Enhertu supplemental new drug application submitted in Japan as adjuvant therapy for patients with HER2 positive early breast cancer
27 February 2026 - Submission based on DESTINY-Breast05 phase 3 trial results, which showed Enhertu reduced the risk of invasive ...
Posted by Michael Wonder on 12 Feb 2026
Datroway supplemental new drug application submitted in Japan for patients with metastatic triple negative breast cancer Who Are Not Candidates for Immunotherapy
12 February 2026 - Based on results from TROPION-Breast02 showing Datroway significantly improved overall survival versus chemotherapy in this patient ...
Posted by Michael Wonder on 07 Oct 2025
Enhertu plus pertuzumab supplemental new drug application submitted in Japan as first-line therapy for patients with HER2 positive metastatic breast cancer
7 October 2025 - Submission based on DESTINY-Breast09 Phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk ...
Posted by Michael Wonder on 26 Aug 2025
Enhertu approved in Japan as first HER2 directed medicine for patients with HER2 low or HER2 ultra-low metastatic breast cancer following at least one endocrine therapy
25 August 2025 - Based on DESTINY-Breast06 phase 3 trial results that showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 21 Aug 2025
Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first
20 August 2025 - According to a recent analysis, Japanese regulators have the shortest time to approval for new drugs compared ...
Posted by Michael Wonder on 21 Feb 2025
Epkinly (epcoritamab) approved by Japan Ministry of Health, Labour and Welfare for additional indication as a treatment for relapsed or refractory follicular lymphoma
20 February 2025 - Approval based on results from two Phase 1/2 EPCORE clinical trials, which demonstrated strong and durable efficacy ...
Posted by Michael Wonder on 05 Feb 2025
Astellas submits new drug application for conditional approval of avacincaptad pegol for geographic atrophy in Japan
5 February 2025 - Ministry of Health, Labour and Welfare to evaluate avacincaptad pegol as potential first and only treatment for ...
Posted by Michael Wonder on 30 Jan 2025
Depemokimab applications accepted for review in China and Japan for asthma with type 2 inflammation and CRSwNP
28 January 2025 - Submissions based on data from positive SWIFT and ANCHOR trials. ...
Posted by Michael Wonder on 27 Dec 2024
Datroway approved in Japan as the first TROP-2 directed therapy for patients with previously treated unresectable or recurrent hormone receptor positive, HER2 negative breast cancer
27 December 2024 - First global approval based on TROPION-Breast01 where Datroway significantly reduced the risk of disease progression or ...
Posted by Michael Wonder on 06 Dec 2024
Otsuka submits new drug application in Japan for bempedoic acid in the treatment of hypercholesterolaemia
26 November 2024 - Otsuka announces the submission of a new drug application to the Japanese Ministry of Health, Labour ...
Posted by Michael Wonder on 04 Oct 2024
Enhertu supplemental new drug application submitted in Japan for patients with HER2 low or HER2 ultra-low metastatic breast cancer
4 October 2024 - Submission based on DESTINY-Breast06 phase 3 trial results that showed Enhertu demonstrated a statistically significant and ...
Posted by Michael Wonder on 26 Sep 2024
Tepezza (teprotumumab) receives approval in Japan for the treatment of active thyroid eye disease
24 September 2024 - Amgen today announced Tepezza (teprotumumab) has been approved for the treatment of active or high clinical activity ...