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FDA again bypasses advisers to remove black-box warnings from menopause treatments

Some experts express concern about ‘lack of transparency’ as agency removes warnings on three estrogen patches

Three more patches for treating menopause will no longer carry black-box warnings about cardiovascular disease, breast cancer and dementia, officials at the US Food and Drug Administration (FDA) said on Friday.

The FDA did not convene an advisory committee and offered few details on the scientific basis for the decision in the press briefing. The news follows the removal of black-box warnings from six menopause treatments in February, as patients across the US struggle with shortages of the patches.

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© Photograph: Bsip Sa/Alamy

© Photograph: Bsip Sa/Alamy

© Photograph: Bsip Sa/Alamy

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FDA scientists opposed Trump administration’s move to ease peptide access

Effort to loosen rules on unproven peptide drugs, favored by RFK Jr, faced fierce pushback from agency scientists

A plan to give people in the United States easier access to unproven peptide drugs favored by the US health secretary, Robert F Kennedy Jr, was opposed by most Food and Drug Administration scientific staff members, who had limited input in drafting the policy, according to six people familiar with its development.

The document posted online on Wednesday by Kennedy’s Department of Health and Human Services (HHS) covers a handful of injectable peptides promoted within the wellness industry for building muscle, healing injuries and boosting energy.

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© Photograph: Alex Wong/Getty Images

© Photograph: Alex Wong/Getty Images

© Photograph: Alex Wong/Getty Images

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Dementia cases in US projected to rise dramatically by 2050, study finds

Increase will add strain on healthcare system already struggling amid cuts by Trump administration, experts say

The number of people with dementia in the United States is projected to increase dramatically over the next 25 years, which will place increasing strain on a healthcare system already struggling to help them amid cuts by the Trump administration, experts say.

According to a new study in Jama Neurology, the annual incidence of new dementia cases globally will more than double, from 11.4m in 2023 to 24.7m in 2050. In the United States, the number of adults diagnosed with dementia each year will increase from 514,000 in 2020 to 1m by 2060, according to a Jama study published in 2024.

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© Photograph: Yaraslau Saulevich/Getty Images

© Photograph: Yaraslau Saulevich/Getty Images

© Photograph: Yaraslau Saulevich/Getty Images

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