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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 |
|---|---|---|---|---|---|---|---|
| Zevtera | NME | ceftobiprole medocaril sodium | To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia | Press Release | 4/3/2024 | ISTX | |
| Xolremdi | NME | mavorixafor | To treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) | 4/26/2024 | X4 PHARMS | ||
| Ojemda | NME | tovorafenib | To treat relapsed or refractory pediatric low-grade glioma | 4/23/2024 | DAY ONE BIOPHARMS | ||
| Anktiva | Biologics | nogapendekin alfa inbakicept-pmln | To treat bladder cancer | 4/22/2024 | ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU | ||
| Lumisight | NME | pegulicianine | To use as an optical imaging agent for the detection of cancerous tissue | 4/17/2024 | LUMICELL | ||
| Ekterly | NME | sebetralstat | To treat acute attacks of hereditary angioedema | 2025-07-03 | KALVISTA PHARMACEUTICALS LTD | ||
| Lynozyfic | Biologics | linvoseltamab-gcpt | To treat relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti CD38 monoclonal antibody | 2025-07-02 | RENGENERON PHARMACEUTICALS, INC. | ||
| Zegfrovy | NME | sunvozertinib | To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with disease progression on or after platinum-based chemotherapy | 2025-07-02 | Dizal (Jiangsu) Pharmaceutical Co., Ltd. | ||
| Andembry | Biologics | garadacimab-gxii | To prevent attacks of hereditary angioedema | 2025-06-16 | CSL BEHRING LLC | ||
| Ibtrozi | NME | taletrectinib | To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer | 2025-06-11 | NUVATION | ||
| Enflonsia | Biologics | clesrovimab-cfor | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season | 2025-06-09 | MERCK SHARP DOHME | ||
| 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 | Drug Trials Snapshot | 2025-04-23 | AKESO BIOPHARMA | |
| Vanrafia | NME | atrasentan | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | Drug Trials Snapshot | 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 | Drug Trials Snapshot | 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 | Drug Trials Snapshot | 2025-02-14 | DECIPHERA PHARMS |
