MANCHESTER, United Kingdom, June 19, 2023 (GLOBE NEWSWIRE) -- 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.
Complete Response Letter is related to the request for additional data and analyses.F2G remains committed to bringing olorofim to patients and intends to meet with FDA in the coming months to align on...
MANCHESTER, United Kingdom, Oct. 13, 2022 (GLOBE NEWSWIRE) -- F2G Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal infections with a high unmet medical need, today announced that it will present new clinical data in three oral presentations and two poster presentations at IDWeek 2022, to be held in Washington, D.C. from October 19-23, 2022.
Novo Holdings has announced that its portfolio company F2G has entered into a strategic collaboration with Japan-based Shionogi & Co. to develop and commercialise its antifungal agent olorofim for invasive fungal infections in Europe and Asia.
MANCHESTER, England and VIENNA, Austria, June 10, 2020 /PRNewswire/ -- F2G Ltd, a UK- and Austria-based biotech developing novel therapies for life-threatening systemic fungal infections, announced today that following the granting of Breakthrough Therapy designation in November (the first antifungal ever to achieve such a designation), the U.S. Food and Drug Administration (FDA) has also granted Qualified Infectious Disease Product (QIDP) designation to its lead first-in-class candidate, olorofim (formerly F901318) for the following requested indications:
F2G Ltd, a UK- and Austria-based biotech company developing novel therapies for life-threatening systemic fungal infections, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its lead first-in-class candidate, olorofim (formerly F901318) for the indication of 'Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species'. Olorofim is the first antifungal agent to be granted Breakthrough Therapy designation.
F2G Ltd, a UK- and Austria-based biotech company developing novel therapies for life-threatening systemic fungal infections, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its lead first-in-class candidate, olorofim (formerly F901318) for the indication of 'Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species'. Olorofim is the first antifungal agent to be granted Breakthrough Therapy designation.