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U.S. Food and Drug Administration (FDA) - Articles and news items

FDA Merck approval head and neck cancer

FDA approves Merck’s head and neck cancer drug

Industry news / 8 August 2016 / Merck

Under the FDA’s accelerated approval regulations, Keytruda, a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumour cells, is approved based on tumour response rate and durability of response. However, continued approval for the drug may be contingent upon verification and description of clinical benefit in the confirmatory trials…

t-cell therapy cancer cells

EU approval in sight as Bellicum’s BPX-501 granted orphan drug designation

Industry news / 5 August 2016 / Bellicum Pharmaceuticals

Bellicum Pharmaceuticals, a clinical stage biopharmaceutical company, has been granted orphan drug designations for both its T-cell therapy product candidate BPX-501 for treatment in hematopoietic stem cell transplantation (HSCT), and for activator agent rimiducid…


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