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药品名称 | 批准类型 | 活性成分 | 适应症 | 上市发布公告 | 临床试验快照 | 批准日期 | 申请机构 |
---|---|---|---|---|---|---|---|
Tryptyr | NME | acoltremon | To treat the signs and symptoms of dry eye disease | 2025-05-28 | ALCON LABS INC | ||
Emrelis | Biologics | telisotuzumab vedotin-tllv | To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy | 2025-05-14 | ABBVIE INC | ||
Avmapki Fakzynja Co-Pack | avutometinib and defactinib | To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy | 2025-05-08 | ||||
Imaavy | Biologics | nipocalimab-aahu | To treat generalized myasthenia gravis | 2025-04-29 | JANSSEN BIOTECH | ||
penpulimab-kcqx | Biologics | penpulimab-kcqx | In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapy | 2025-04-23 | AKESO BIOPHARMA | ||
Vanrafia | NME | atrasentan | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | 2025-04-02 | NOVARTIS | ||
Qfitlia | NME | fitusiran | To prevent or reduce the frequency of bleeding episodes in hemophilia A or B | Press Release | 2025-03-28 | GENZYME CORP | |
Blujepa | NME | gepotidacin | To treat uncomplicated urinary tract infections | 2025-03-25 | GLAXOSMITHKLINE | ||
Romvimza | NME | vimseltinib | To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity | 2025-02-14 | DECIPHERA PHARMS | ||
Gomekli | NME | mirdametinib | To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection | 2025-02-11 | SPRINGWORKS | ||
Journavx | NME | suzetrigine | To treat moderate to severe acute pain | Press Release | 2025-01-30 | VERTEX PHARMS INC | |
Grafapex | NME | treosulfan | For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome | 2025-01-21 | MEDEXUS | ||
Datroway | Biologics | datopotamab deruxtecan-dlnk | To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease | 2025-01-17 | DAIICHI SANKYO INC | ||
Alhemo | Biologics | concizumab-mtci | For routine prophylaxis to prevent bleeding episodes in hemophilia A and B | 2024-12-20 | NOVO NORDISK INC | ||
Alyftrek | NME | vanzacaftor, tezacaftor, and deutivacaftor | To treat cystic fibrosis | 2024-12-20 | VERTEX PHARMS INC | ||
Tryngolza | NME | olezarsen | To treat familial chylomicronemia syndrome | 2024-12-19 | IONIS PHARMS INC | ||
Ensacove | NME | ensartinib | To treat non-small cell lung cancer | 2024-12-18 | XCOVERY | ||
Crenessity | NME | crinecerfont | To treat classic congenital adrenal hyperplasia | Press Release | 2024-12-13 | NEUROCRINE | |
Unloxcyt | NME | cosibelimab-ipdl | To treat cutaneous squamous cell carcinoma | 2024-12-13 | CHECKPOINT THERAPEUTICS INC | ||
Bizengri | Biologics | zenocutuzumab-zbco | To treat non-small cell lung cancer and pancreatic adenocarcinoma | 2024-12-04 | MERUS N.V. |