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FDA Gives Accelerated Approval for Risky Alzheimer's Pill
1 day ago - By Mercola
The U.S. Food and Drug Administration granted accelerated approval for the Alzheimer's disease drug lecanemab. The drug, a monoclonal antibody, binds to amyloid beta in the brain.
An 18-month study published in the New England Journal of Medicine 1 found Leqembi reduced markers of amyloid in early Alzheimer's disease and led to “moderately less decline” in cognition and function compared to placebo. However, the study added, the drug was “associated with adverse events.” 2
The FDA granted accelerated approval of Leqembi based on the observed reduction of amyloid beta plaque. The study...
Read more ...FDA puts focus on lead levels in baby food
1 day ago - By Food Safety
The U.S. Food and Drug Administration Tuesday announced draft guidance for the industry on “action levels” for lead in processed foods that are intended for babies and children under two years old, for the purpose of reducing potential health effects in this vulnerable population from dietary exposure to lead.
According to the FDA, the proposed “action levels” would result in significant reductions in exposure to lead from food while ensuring the availability of nutritious foods. The guidance is part of Closer to Zero , which sets forth the FDA's science-based approach to continually...
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