Eric Green leaves his job as director of the NIH National Human Genome Research Institute

Early endpoints are a balance of risk and benefit

Early endpoints have the potential to get effective drugs to patients faster, but granting approval to drugs—even accelerated approval—comes with the risk that ineffective or even harmful drugs will be given to patients.

October 29, 2025

Vol.51 No.39

Clinical Regulatory News Trials & Tribulations

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

In April 2025, announcements from the two most influential biomedical agencies in the US, the FDA and the NIH, declared that both will seek to reduce and minimize animal-based testing and experimentation. These declarations sparked joy in some circles, and deep concern in others that was reflected in a 28% fall in the share price of Charles River Labs (NYSE: NYSE:CRL).

October 17, 2025

Vol.51 No.38

By Edison T. Liu

News Analysis Regulatory News

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

Bowing to the growing animal rights movement, FDA and NIH have made policy changes to discourage animal testing, instead favoring alternative research models.

October 17, 2025

Vol.51 No.38

By Claire Marie Porter and Jacquelyn Cobb

Cancer Policy

NIH announces restrictions on human biospecimen sharing with China and other foreign adversaries

NIH has published a policy that prohibits U.S. researchers and NIH grant recipients working with human biospecimens to share this data with “countries of concern.” That list includes China (including Hong Kong and Macau), Russia, Iran, North Korea, Cuba, and Venezuela.

United for Medical Research report shows NIH funding benefits patients, researchers

United for Medical Research conducted a report surveying patients and researchers on why NIH, and NIH funding matters to them.

October 10, 2025

Vol.51 No.37

By Claire Marie Porter

NCI

Anthony Letai sworn in as 18th NCI director

Anthony G. Letai, accompanied by his wife Jean, was sworn in by HHS Secretary Kennedy as the 18th NCI Director on Sept. 29.Anthony G. Letai, a physician-scientist at Harvard Medical School and Dana-Farber Cancer Institute, has been officially named the 18th director of the National Cancer Institute.

October 03, 2025

Vol.51 No.36

By Claire Marie Porter

Eric Green leaves his job as director of the NIH National Human Genome Research Institute

YOU MAY BE INTERESTED IN

Early endpoints are a balance of risk and benefit

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

NIH announces restrictions on human biospecimen sharing with China and other foreign adversaries

United for Medical Research report shows NIH funding benefits patients, researchers

Anthony Letai sworn in as 18th NCI director

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Eric Green leaves his job as director of the NIH National Human Genome Research Institute

YOU MAY BE INTERESTED IN

Early endpoints are a balance of risk and benefit

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

How animal testing became a MAHA political wedge issueWhile cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

NIH announces restrictions on human biospecimen sharing with China and other foreign adversaries

United for Medical Research report shows NIH funding benefits patients, researchers

Anthony Letai sworn in as 18th NCI director

Never miss an issue!

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How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough