2025– date –
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Oncology Drug Approval News Flash: Treosulfan (Grafapex) Approved by FDA for Conditioning Prior to allo-HSCT
【FDA Approval Alert】medac's treosulfan (Grafapex) Approved for Conditioning in AML/MDS allo-HSCT (January 21, 2025) On January 21, 2025, the U.S. FDA approved treosulfan (Grafapex) in combination with fludarabine as part of a condition... -
Cancer Drug News Flash: pembrolizumab (Keytruda) FDA Approved for Resectable Head and Neck Squamous Cell Carcinoma
FDA Approval Alert: Merck's pembrolizumab (Keytruda) Approved for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (June 12, 2025) On June 12, 2025, the FDA approved pembrolizumab (Keytruda) for the treatment of resectab... -
Oncology Drug Approval News Flash: Mitomycin (Zusduri) Approved by FDA for Recurrent Low-Grade Intermediate-Risk NMIBC
【FDA Approval Alert】UroGen Pharma's mitomycin (Zusduri) Approved for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (June 12, 2025) On June 12, 2025, the U.S. FDA approved mitomycin (Zusduri) for adult patient... -
Oncology Drug Approval News Flash: Taletrectinib (Ibtrozi) Approved by FDA for ROS1-Positive NSCLC
【FDA Approval Alert】Nuvation Bio's taletrectinib (Ibtrozi) Approved for ROS1-Positive Non-Small Cell Lung Cancer (June 11, 2025) On June 11, 2025, the U.S. FDA approved taletrectinib (Ibtrozi) for adult patients with locally advanced o... -
Oncology Drug Approval News Flash: Darolutamide (Nubeqa) Approved by FDA for Metastatic Castration-Sensitive Prostate Cancer
【FDA Approval Alert】Bayer's darolutamide (Nubeqa) Approved for Metastatic Castration-Sensitive Prostate Cancer (June 3, 2025) On June 3, 2025, the U.S. FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate can... -
Oncology Drug Approval News Flash: Retifanlimab-dlwr (Zynyz) Approved by FDA for Squamous Cell Carcinoma of the Anal Canal
【FDA Approval Alert】Incyte's retifanlimab-dlwr (Zynyz) Approved for Squamous Cell Carcinoma of the Anal Canal (May 15, 2025) On May 15, 2025, the U.S. FDA approved retifanlimab-dlwr (Zynyz) for adults with inoperable locally recurrent ... -
Oncology Drug Approval News Flash: Telisotuzumab Vedotin-tllv (Emrelis) Receives Accelerated FDA Approval for High c-Met NSCLC
【FDA Approval Alert】AbbVie's telisotuzumab vedotin-tllv (Emrelis) Accelerated Approval for High c-Met Non-Small Cell Lung Cancer (May 14, 2025) On May 14, 2025, the U.S. FDA granted accelerated approval to telisotuzumab vedotin-tllv (E... -
Oncology Drug Approval News Flash: Belzutifan (Welireg) Approved by FDA for Pheochromocytoma and Paraganglioma
【FDA Approval Alert】Merck's belzutifan (Welireg) Approved for Pheochromocytoma and Paraganglioma (May 14, 2025) On May 14, 2025, the U.S. FDA approved belzutifan (Welireg) for patients aged 12 years and older with locally advanced, unr... -
Oncology Drug Approval News Flash: Avutometinib + Defactinib (Avmapki Fakzynja Co-pack) Receives Accelerated FDA Approval for KRAS-Mutated LGSOC
【FDA Approval Alert】Verastem's avutometinib + defactinib Approved for KRAS-Mutated Low-Grade Serous Ovarian Cancer (May 8, 2025) On May 8, 2025, the U.S. FDA granted accelerated approval to avutometinib + defactinib (Avmapki Fakzynja C... -
Oncology Drug Approval News Flash: Penpulimab-kcqx (Akeso) Approved by FDA for Non-Keratinizing Nasopharyngeal Carcinoma
【FDA Approval Alert】Akeso's penpulimab-kcqx Approved for Non-Keratinizing Nasopharyngeal Carcinoma (April 23, 2025) On April 23, 2025, the U.S. FDA approved penpulimab-kcqx (Akeso) for adult patients with recurrent or metastatic non-ke...
