PMDA · MHLW · monthly list
All drugs approved in Japan in May 2024, in English.
Last updated: 2026-10-02 · 6 approvals
Japan approved 6 drugs in May 2024 (approval date: 2024-05-17): 6 new indication.
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-05-17 | Prevymis プレバイミス | Letermovir レテルモビル | MSD K.K. MSD(株) | Prophylaxis of cytomegalovirus disease in organ transplantation 臓器移植におけるサイトメガロウイルス感染症の発症抑制 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-05-17 | Mektovi メクトビ | Binimetinib ビニメチニブ | Ono Pharmaceutical Co., Ltd. 小野薬品工業(株) | Treatments of unresectable BRAF mutation-positive thyroid cancer that has progressed after cancer chemotherapy and unresectable BRAF mutation-positive anaplastic thyroid cancer がん化学療法後に増悪したBRAF遺伝子変異を有する根治切除不能な甲状腺癌及びBRAF遺伝子変異を有する根治切除不能な甲状腺未分化癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-05-17 | 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 biliary tract cancer 治癒切除不能な胆道癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-05-17 | 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 gastric cancer 治癒切除不能な進行・再発の胃癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-05-17 | G-Lasta ジーラスタ | Pegfilgrastim ペグフィルグラスチム(遺伝子組換え) | Kyowa Kirin Co., Ltd. 協和キリン(株) | Mobilization of hematopoietic stem cells to the peripheral blood for autologous hematopoietic stem cell transplantation 造血幹細胞の末梢血中への動員 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-05-17 | Braftovi ビラフトビ | Encorafenib エンコラフェニブ | Ono Pharmaceutical Co., Ltd. 小野薬品工業(株) | Treatments of unresectable BRAF mutation-positive thyroid cancer that has progressed after cancer chemotherapy and unresectable BRAF mutation-positive anaplastic thyroid cancer がん化学療法後に増悪したBRAF遺伝子変異を有する根治切除不能な甲状腺癌及びBRAF遺伝子変異を有する根治切除不能な甲状腺未分化癌 | New indication standard | — | — | — | — | [1] [2] [3] |
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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