The European Commission has renewed conditional approval for PTC Therapeutics (US)'s Translarna (ataluren). The approval dispels uncertainty that had surrounded the future of the Duchenne muscular dystrophy treatment in Europe. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a supplemental information request related to the drug's efficacy and risk-benefit profile in September 2016. As part of the renewal conditions, PTC is required to conduct an 18-month placebo-controlled, randomised study to analyse Translarna's risk-benefit performance in Duchenne muscular dystrophy. In addition, the company is obliged to conduct a further 18-month study in patients that are transitioned to treatment with Translarna. The results from these forthcoming studies are expected to be released in the first quarter of 2021.