Morphogenesis receives FDA ‘fast track’ designation for skin cancer vaccine

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A skin cancer vaccination called IFx-Hu2.0 received FDA “fast track” designation to treat patients with advanced cutaneous melanoma who have not responded to other therapies and medication.

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Companies vying for accelerated approval and devising strategies for confirmatory trials would be best served by seeking prospective sign-off from FDA, agency officials say.  Officials from the FDA Oncology Center of Excellence described these best practices in a perspective piece in the Sept. 21 issue of The New England Journal of Medicine and discussed the...