FDA Green-Lights Second Alzheimer Drug, Donanemab

The US Food and Drug Administration (FDA) recently approved donanemab, a monoclonal antibody to treat Alzheimer disease in its early stages. Marketed by Eli Lilly as Kisunla, the drug is the second to receive the FDA’s go-ahead for slowing Alzheimer disease, after lecanemab. Like lecanemab, donanemab is designed to clear amyloid plaque in people with mild cognitive impairment or mild dementia.

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Agosto 2024

FDA Proposes Guidance for Increasing Diversity in Clinical Trials

The US Food and Drug Administration (FDA) recently announced new draft guidance that aims to increase the number of participants from underrepresented populations in clinical trials in the US and globally by requiring medical product sponsors to submit strategies, known as diversity action plans. Age, ethnicity, sex, and race are all factors that can contribute to clinical trial diversity, but sponsors should also consider types of diversity beyond those, such as geographic location, sexual orientation, or socioeconomic status, the FDA wrote.

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Agosto 2024

FDA Approval of Mifepristone

This Viewpoint discusses the recent US Supreme Court ruling allowing mifepristone—a drug used in medication abortion—to be widely available in the US, summarizes the history of challenges to the availability of mifepristone, and highlights reasons for concerns that remain after the Court’s current ruling.

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Agosto 2024