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FDA says no to F2G’s novel antifungal

F2G’s attempt to end a two-decade drought in novel therapies for invasive fungal infections has hit a hurdle after the FDA said it was unable to approve its olorofim candi

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FDA delays review of GSK’s momelotinib for myelofibrosis

GSK won’t be hearing from the FDA this month about its marketing application for momelotinib as a treatment for myelofibrosis patients with anaemia after all.

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FDA panel gives unanimous support to Leqembi

The first full regulatory approval for an amyloid-targeting therapy for Alzheimer’s disease could come within a month, after an expert panel voted 6 to 0 in favour of Eisa

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Eisai files Leqembi in Korea, as US prospects firm up

Eisai has filed for approval of its Alzheimer’s disease therapy Leqembi in South Korea, just ahead of an FDA advisory committee meeting that has raised confidence that the

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FDA panel vote dashes Intercept’s NASH hopes

Intercept Pharma is facing an uphill battle to get FDA approval of its OCA therapy for non-alcoholic steatohepatitis (NASH) once again, after FDA advisors comprehensively

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FDA advisors back Pfizer’s RSV shot for maternal use

An FDA advisory committee has endorsed Pfizer’s respiratory syncytial virus (RSV) vaccine for use in expectant mothers, potentially opening up a niche for the shot, where

FDA says no to F2G’s novel antifungal

FDA delays review of GSK’s momelotinib for myelofibrosis

FDA panel gives unanimous support to Leqembi

Eisai files Leqembi in Korea, as US prospects firm up

FDA panel vote dashes Intercept’s NASH hopes

FDA advisors back Pfizer’s RSV shot for maternal use

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