FDA panel unanimously endorsed an Alzheimer's drug that's shown to slow disease progression.
The Prescription Drug User Fee Act action date is set for the traditional approval of Leqembi on July 6, 2023.
But the drug and the drug manufacturers found themselves in a fix when three deaths were reported during clinical trials. Axiosthat the FDA staff said that the safety concerns "do not appear to preclude traditional approval," though they could not rule out the drug's role in the deaths.
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