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RSS FeedPosted 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 ...
Posted by Michael Wonder on 25 Sep 2024
Lilly's Kisunla (donanemab-azbt) approved in Japan for the treatment of early symptomatic Alzheimer's disease
24 September 2024 - Japan is the second major market where Kisunla has received approval. ...
Posted by Michael Wonder on 25 Sep 2024
Takeda receives approval for Fruzaqla (fruquintinib) in Japan for the treatment of unresectable advanced or recurrent colorectal cancer
24 September 2024 - Approval based on results from positive, global, Phase 3 FRESCO-2 trial. ...
Posted by Michael Wonder on 01 Aug 2024
SanBio obtains marketing approval for Akuugo suspension for intracranial implantation (vandefitemcel) as a therapeutic agent for improving chronic motor paralysis from traumatic brain injury
31 July 2024 - SanBio hereby announces that today on 31 July 2024, it obtained conditional and time limited marketing approval ...
Posted by Michael Wonder on 26 Jun 2024
UCB’s epilepsy drug Briviant (brivaracetam) approved in Japan for treatment of focal onset seizures
26 June 2024 - Approval is supported by positive results from a Phase 3 clinical study which evaluated the efficacy ...
Posted by Michael Wonder on 25 Jun 2024
Ezharmia approved in Japan as first dual EZH1 and EZH2 inhibitor therapy for patients with peripheral T-cell lymphoma
24 June 2024 - Approval based on VALENTINE-PTCL01 results showing a clinically meaningful objective response rate of 43.7% in patients ...
Posted by Michael Wonder on 25 Jun 2024
Tagrisso with the addition of chemotherapy approved in Japan as new first-line treatment for patients with EGFR mutated advanced lung cancer
25 June 2024 - Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...