Longer to wait for promising new antifungal after FDA delay

20 June 2023

Hopes for what would be the first new antifungal based on a novel mechanism for decades have been dealt a blow by the US Food and Drug Administration.

Manchester, UK-based antifungal specialist F2G has received a Complete Response Letter (CRL) from the US medicines regulator for its rare fungal mold candidate olorofim.

The US FDA has asked for additional data and analyses which the company said would require “time and resources that extend beyond the current review period.”

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