FDA’s Oncology Center of Excellence

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Accelerating drug development

22 February 2023 | By Dave Elder (David P Elder Constultancy)

Here, Dave Elder explores how a ‘quick-approval, quick-withdrawal from the market’ approach is used to accelerate drug development.

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FDARA implementation guidance for paediatric studies of molecularly targeted oncology drugs

2 August 2021 | By Sanyam Gandhi (Takeda Pharmaceuticals)

This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).

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FDA approves new targeted treatment for acute myeloid leukemia

2 August 2017 | By Dr Zara Kassam (European Pharmaceutical Review)

The U.S. Food and Drug Administration has granted the approval of Idhifa to Celgene Corporation and RealTime IDH2 Assay to Abbott Laboratories...