23 November 2021 - FDA PDUFA goal date extended by three months to 28 February 2022.
Amryt today announces that the US FDA has extended the review period for the new drug application for Oleogel-S10 for the treatment of the cutaneous manifestations of junctional and dystrophic epidermolysis bullosa, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.