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Tag: Accelerated Approval

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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...
accelerated-approval

Zanidatamab-hrii is approved by the USFDA for previously treated unresectable or metastatic HER2-positive biliary tract cancer

 On November 20, 2024, the Food and Drug Administration granted accelerated approval for zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc.), a bispecific HER2-targeted antibody, for previously tr...
accelerated-approval

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