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Tampa biotech advances potential treatment of melanoma

November 13, 2020 - The U.S. Food and Drug Administration has granted orphan drug designation to a potential treatment of melanoma being developed by Morphogenesis, a privately held, clinical stage biotechnology company in Tampa. The designation is for medications that are intended for use in diseases which affect fewer than 200,000 persons in the U.S., and provides sponsors with  eligibility for a seven-year period of market exclusivity in the U.S. following product approval, as well as FDA assistance in clinical trial design and an exemption from FDA user fees.  Morphogenesis' drug candidate is for the treatment of stage IIB to stage IV melanoma. Late stage melanoma is among the deadliest forms of skin cancer, affecting as many as 62,748 Americans.

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