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Datopotamab deruxtecan-dlnk is approved by the USFDA for EGFR-mutated non-small cell lung cancer

On June 23, 2025, the Food and Drug Administration conferred accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epiderm...

Tafasitamab-cxix is approved by the USFDA for relapsed or refractory follicular lymphoma

On June 18, 2025, the Food and Drug Administration sanctioned tafasitamab-cxix (Monjuvi, Incyte Corporation) in conjunction with lenalidomide and rituximab for adults with relapsed or refractory folli...

Neoadjuvant and adjuvant pembrolizumab is approved by the USFDA for resectable locally advanced head and neck squamous cell carcinoma

On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with advanced head and neck squamous cell carcinoma (HNSCC) that can be surgically removed and sh...

Mitomycin intravesical solution is approved by the USFDA for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adults with recurring low-grade intermediate-risk non-muscle invasive bladder c...

Taletrectinib is approved by the USFDA for ROS1-positive non-small cell lung cancer

On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a type of medicine that blocks certain enzymes, for people with advanced or spreading ROS1-posit...

Darolutamide is approved by the USFDA for metastatic castration-sensitive prostate cancer

On June 3, 2025, the Food and Drug Administration (FDA) sanctioned darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA has...

Retifanlimab-dlwr with carboplatin and paclitaxel is approved by the USFDA and as a single agent for squamous cell carcinoma of the anal canal

On May 15, 2025, the Food and Drug Administration sanctioned retifanlimab-dlwr (Zynyz, Incyte Corporation) in conjunction with carboplatin and paclitaxel for the initial treatment of people with inope...

Accelerated approval is granted by the USFDA to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression

On May 14, 2025, the Food and Drug Administration granted accelerated approval for telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-targeted antibody and microtubule inhibitor conjugate, for...

Belzutifan is approved by the USFDA for pheochromocytoma or paraganglioma

On May 14, 2025, the Food and Drug Administration sanctioned belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients aged 12 and older diagnosed with locally advanced, unresectabl...

Accelerated approval is granted by the USFDA to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

On May 8, 2025, the Food and Drug Administration approved the use of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adults with KRAS-mutated recurrent low-grade serous ovar...

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