• STAT+: Pharmalittle: Inside the FDA's contentious Aduhelm approval; Peter Bach heading to liquid biopsy startup

    1 month ago - By STAT

    Good morning! Elizabeth Cooney here, sitting in for Ed Silverman, who would no doubt be reminding us that we've made it halfway through the week, so why not carry on, cup of stimulation and and clutch of news items in hand?
    Chastened after a decisively negative review from outside advisers, the Food and Drug Administration convened a series of internal meetings in March and April where top officials hammered out a plan to approve Biogen's Alzheimer's drug, Aduhelm, STAT reports, based on a series of documents released Tuesday by the FDA to explain its decision to use a truncated pathway to...
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