Posted by Michael Wonder on 19 Jun 2023
F2G receives complete response letter from FDA for new drug application for Olorofim for the treatment of invasive fungal infections; plans resubmission with additional data and analyses
19 June 2023 - Complete response letter is related to the request for additional data and analyses.
F2G today announced that the US FDA issued a complete response letter regarding the new drug application for olorofim, an investigational anti-fungal, for the treatment of invasive fungal infections in patients who have limited or no treatment options.
