Daniel O'Day, AP Images
FDA hands Gilead a stunning rejection for blockbuster RA candidate filgotinib, dealing CEO O’Day a major setback
In a surprise twist, the FDA has rejected Gilead’s marketing application for filgotinib, dealing a body blow to Daniel O’Day’s hopes for a rapid improvement in the big biotech’s drug portfolio with a blockbuster addition.
Late on Tuesday, Gilead $GILD put out word that the agency had turned thumbs-down on their application for rheumatoid arthritis, saying that regulators wanted to see more data from two ongoing safety studies of the drug.
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