regulatory

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Takeda pulls its dengue vaccine filing from FDA

Takeda has unexpectedly withdrawn its marketing application with the FDA for dengue fever vaccine TAK-003 and said it will reconsider whether it will attempt to bring it t

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FDA sets out its thinking on psychedelic drug trials

The FDA has published its first-ever guidance document on clinical trials with psychedelic drugs, an emerging treatment category for psychiatric and substance use disorder

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Intercept changes course as OCA is rejected for NASH again

Intercept Pharma has conceded defeat in its battle to get obeticholic acid (OCA) approved as a treatment for non-alcoholic steatohepatitis (NASH) after the FDA rejected it

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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

Takeda pulls its dengue vaccine filing from FDA

FDA sets out its thinking on psychedelic drug trials

Intercept changes course as OCA is rejected for NASH again

FDA says no to F2G’s novel antifungal

FDA delays review of GSK’s momelotinib for myelofibrosis

FDA panel gives unanimous support to Leqembi

CDC signs off on advice ending universal hepatitis B jabs

How to meet your physicians where they are online

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