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News about " Ministry of Health, Labour and Welfare"
Japan Approves Merck's Keytruda Qlex for Subcutaneous Use
Merck’s Keytruda Qlex receives MHLW approval in Japan for subcutaneous use across all locally approved Keytruda indications.
Ministry Of Health, Labour And Welfare | 22/09/2026 | By News Bureau
Japan Approves Enhertu and Datroway for New First-Line Metastatic Breast Cancer Indications
Japan has approved new first-line metastatic breast cancer indications for Daiichi Sankyo’s Enhertu and Datroway, expanding treatment options for patients with HER2-positive and triple-negative breast cancer.
Ministry Of Health, Labour And Welfare | 17/09/2026 | By News Bureau | 309
GSK's Shingrix Prefilled Syringe Approves in Japan
GSK’s Shingrix prefilled syringe receives approval in Japan for the prevention of shingles, offering a ready-to-use alternative to the existing two-vial presentation.
Ministry Of Health, Labour And Welfare | 11/09/2026 | By News Bureau
Insmed's Brinsupri Wins Japan Approval for Non-Cystic Fibrosis Bronchiectasis
Insmed’s Brinsupri (brensocatib) has secured MHLW approval in Japan for non-cystic fibrosis bronchiectasis, expanding access to a new treatment option for patients with the chronic and progressive lung disease.
Ministry Of Health, Labour And Welfare | 26/08/2026 | By News Bureau | 101
Chugai Files for Expanded Tecentriq Use in MSI-High Colon Cancer in Japan
Chugai Pharmaceutical has filed a Japanese regulatory application seeking an expanded Tecentriq indication for adjuvant treatment of MSI-High colon cancer. The filing is backed by Phase 3 ATOMIC data showing three-year disease-free survival of 86.3 percent with Tecentriq plus mFOLFOX6, versus 76.2 percent with chemotherapy alone.
Ministry Of Health, Labour And Welfare | 17/08/2026 | By News Bureau | 119
Pharming Launches Joenja in Japan for APDS Patients Aged 4 and Older
Pharming has launched Joenja in Japan for APDS patients aged 4 years and older, making Japan the first market to offer the treatment commercially to children aged 4–11.
Ministry Of Health, Labour And Welfare | 14/08/2026 | By News Bureau | 115
GSK plc Secures Japan Orphan Drug Status for Ris-Rez in Small-Cell Lung Cancer
Japan’s health ministry grants orphan drug designation to GSK’s investigational ADC Ris-Rez for SCLC, supported by early clinical data showing durable responses in advanced-stage patients.
Ministry Of Health, Labour And Welfare | 24/03/2026 | By News Bureau | 218
Japan's MHLW accepts GSK's Bepirovisen for Review to Treat Chronic Hepatitis B
Japan’s health ministry has accepted GSK’s new drug application for investigational antisense therapy bepirovirsen, after Phase III trials showed significantly higher functional cure rates in chronic hepatitis B patients.
Ministry Of Health, Labour And Welfare | 27/02/2026 | By News Bureau | 835
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