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Afamelanotide (Scenesse, Clinuvel Pharmaceuticals) is a linear MC1R selective tridecapeptide, approved by the FDA on October 8, 2019, and by the EMA on December 22, 2014, exclusively for the treatment of erythropoietic protoporphyria (EPP) in adults

De- and remyelination in the CNS white and grey matter induced by cuprizone: the old, the new, and the unexpected

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The agency is committed to investigating these reports to assess the potential public health risks and determine the appropriate regulatory response