FDA Denies Application for New Antifungal Drug

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FDA Denies Application for New Antifungal Drug
FDAAntifungal DrugOlorofim
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The Food and Drug Administration has denied an application for a new antifungal drug called olorofim, requesting more data. Fungal infections pose a growing threat to human health, and doctors are in need of new medicines to combat this problem.

Last summer, the Food and Drug Administration denied an application for a new antifungal drug called olorofim, sending it back to the company with a request for more data. If approved, it would have been the first time since the early 2000s that the FDA cleared an antifungal that works in an entirely novel way.

It couldn’t come at a more important time: In recent years, the potential danger fungal infections pose to human health has become more and more apparent, as fungi either evolve to evade treatments or spread beyond their typical geographical regions. Doctors around the world are desperate for new medicines to combat the growing threat. “The problem with fungal diseases has gotten to the point where the World Health Organization has recognized it as a widespread threat,” said Dr. Arturo Casadevall, a microbiologist and chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health in Baltimor

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