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New FDA Guidance Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics

On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle.

Marjoriee zettlerDrug administrationOncologic drugs advisory committeeRegor pharmaceuticals incDrug administration expedited developmentUs government accountability officeOncology centerDrug administration accelerated approval of malignant hematologyRegor pharmaceuticalsProject confirmReduce riskRequire stronger evidence of safety andDrug omnibus reform actConsolidated appropriations actMantle cell lymphomaMarginal zone lymphoma

New FDA Guidance Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics

On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle.

Marjoriee zettlerOncologic drugs advisory committeeDrug administrationUs government accountability officeDrug administration accelerated approval of malignant hematologyOncology centerDrug administration expedited developmentRegor pharmaceuticals incRegor pharmaceuticalsProject confirmReduce riskRequire stronger evidence of safety andDrug omnibus reform actConsolidated appropriations actMantle cell lymphomaMarginal zone lymphoma

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