PMDA · MHLW · monthly list
All drugs approved in Japan in May 2025, in English.
Last updated: 2026-10-02 · 10 approvals
Japan approved 10 drugs in May 2025 (approval date: 2025-05-19): 6 new indication, 2 new active ingredient, 2 new dosage. Median lag vs FDA for this month: -0.4 years (-157 days) (n=1).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-05-19 | mRESVIA エムレスビア | mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation RSウイルスの融合前安定化F糖タンパク質をコードするmRNA | Moderna Japan Co., Ltd. モデルナ・ジャパン(株) | Prevention of disease caused by RS virus infection RSウイルスによる感染症の予防 | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2025-05-19 | Vabysmo バビースモ硝子体内 | Faricimab ファリシマブ(遺伝子組換え) Orphan | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Treatment of choroidal neovascularization associated with angioid streaks 脈絡膜新生血管を伴う網膜色素線条 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-05-19 | Tagrisso タグリッソ | Osimertinib mesilate オシメルチニブメシル酸塩 | AstraZeneca K.K. アストラゼネカ(株) | Maintenance treatment for locally-advanced, unresectable epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer following definitive chemoradiation therapy EGFR遺伝子変異陽性の切除不能な局所進行の非小細胞肺癌における根治的化学放射線療法後の維持療法 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-05-19 | Spikevax スパイクバックス | mRNA encoding the spike protein of SARS-CoV-2 SARS-CoV-2のスパイクタンパク質をコードするmRNA | Moderna Japan Co., Ltd. モデルナ・ジャパン(株) | Prevention of disease caused by SARS-CoV-2 infection (COVID-19) SARS-CoV-2による感染症の予防 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2025-05-19 | Slinda スリンダ | Drospirenone ドロスピレノン | ASKA Pharmaceutical Co., Ltd. あすか製薬(株) | Contraception 避妊 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-05-19 | Scemblix セムブリックス | Asciminib hydrochloride アシミニブ塩酸塩 | Novartis Pharma K.K. ノバルティスファーマ(株) | Treatment of chronic myelogenous leukemia 慢性骨髄性白血病 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-05-19 | Rybrevant ライブリバント | Amivantamab アミバンタマブ(遺伝子組換え) | Janssen Pharmaceutical K.K. ヤンセンファーマ(株) | Treatment of unresectable advanced or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer EGFR遺伝子変異陽性の切除不能な進行・再発の非小細胞肺癌 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2025-05-19 | Keytruda キイトルーダ | Pembrolizumab ペムブロリズマブ(遺伝子組換え) | MSD K.K. MSD(株) | Treatment of unresectable advanced or recurrent malignant pleural mesothelioma 切除不能な進行・再発の悪性胸膜中皮腫 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-05-19 | Fabhalta ファビハルタ | Iptacopan hydrochloride hydrate イプタコパン塩酸塩水和物 Orphan | Novartis Pharma K.K. ノバルティスファーマ(株) | Treatment of complement 3 glomerulopathy C3腎症 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2025-05-19 | Blenrep ブーレンレップ | Belantamab mafodotin ベランタマブ マホドチン(遺伝子組換え) Orphan | GlaxoSmithKline K.K. グラクソ・スミスクライン(株) | Treatment of relapsed or refractory multiple myeloma 再発又は難治性の多発性骨髄腫 | New active ingredient orphanpriority | 2025-10-23 | 2020-08-25 | 157 d earlier Japan first | 1,728 d 4.7 y | [1] [2] [3] [4] [5] |
Click a column header to sort. Lag = days between the FDA (or EMA) approval and the Japanese approval of the same active ingredient; “Japan first” means Japan approved it earlier. Lag is shown only when a matching foreign approval was found. JP = no English name found; Japanese kept.
Source: PMDA / MHLW (PDL1.0). Unofficial English translation, edited by Japan Pharma Regulatory Brief.
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