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
MANCHESTER, United Kingdom, June 15, 2023 – F2G Ltd. today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for olorofim, an investigational antifungal, for the treatment of invasive fungal infections in patients who have limited or no treatment options. According to the CRL, FDA […]