FDA opens application for Orphan Products Clinical Trials Grant Program

FDA’s OCE publishes three final guidances to increase clinical trial enrollment

FDA’s Oncology Center of Excellence has published three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs.

After two CRLs, FDA advisory committee votes in favor of Replimune’s melanoma drug

FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 10:3 in favor of Replimune’s Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

July 31, 2026

Vol.52 No.30

Podcast

Hegseth offers soldiers testosterone and FDA loosens safety warnings. Is the science there?

Last week, the Pentagon posted a video on X announcing they will be mandating testosterone screening for troops in the military aged 30 and above. If they test low, they will be offered voluntary testosterone replacement therapy.

July 29, 2026

Regulatory News

Hegseth orders testosterone testing for troops as FDA moves to loosen TRT prostate cancer warnings
Experts caution the move amounts to a “huge, unregulated, natural experiment”

In a video captioned “The High-T Department of War” and posted on X, Secretary of Defense Pete Hegseth announced that he was authorizing a screening program for troops to ensure “you have the right testosterone levels to operate at your absolute best.”

July 24, 2026

Vol.52 No.29

By Claire Marie Porter

In Brief

The V Foundation announces recipients of the 2026 Breaking Barriers in Cancer Research Award

The V Foundation for Cancer Research, a top-rated cancer research charity, announced $11.2 million in funding awarded to 14 scientists through its 2026 Breaking Barriers in Cancer Research Award program.

July 24, 2026

Vol.52 No.29

In Brief

Sylvester’s Marlon Wong receives Gabrielle’s Angel Foundation grant to study CIPN

Marlon L. Wong, associate professor of clinical physical therapy at the University of Miami Miller School of Medicine, was awarded a grant from Gabrielle’s Angel Foundation for Cancer Research. The three-year, $225,000 award will support research focused on improving quality of life for patients living with chemotherapy-induced peripheral neuropathy and other long-term effects of cancer treatment.

July 24, 2026

Vol.52 No.29

FDA opens application for Orphan Products Clinical Trials Grant Program

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FDA’s OCE publishes three final guidances to increase clinical trial enrollment

After two CRLs, FDA advisory committee votes in favor of Replimune’s melanoma drug

Hegseth offers soldiers testosterone and FDA loosens safety warnings. Is the science there?

Hegseth orders testosterone testing for troops as FDA moves to loosen TRT prostate cancer warnings
Experts caution the move amounts to a “huge, unregulated, natural experiment”

The V Foundation announces recipients of the 2026 Breaking Barriers in Cancer Research Award

Sylvester’s Marlon Wong receives Gabrielle’s Angel Foundation grant to study CIPN

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FDA opens application for Orphan Products Clinical Trials Grant Program

YOU MAY BE INTERESTED IN

FDA’s OCE publishes three final guidances to increase clinical trial enrollment

After two CRLs, FDA advisory committee votes in favor of Replimune’s melanoma drug

Hegseth offers soldiers testosterone and FDA loosens safety warnings. Is the science there?

Hegseth orders testosterone testing for troops as FDA moves to loosen TRT prostate cancer warningsExperts caution the move amounts to a “huge, unregulated, natural experiment”

The V Foundation announces recipients of the 2026 Breaking Barriers in Cancer Research Award

Sylvester’s Marlon Wong receives Gabrielle’s Angel Foundation grant to study CIPN

Never miss an issue!

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Hegseth orders testosterone testing for troops as FDA moves to loosen TRT prostate cancer warnings
Experts caution the move amounts to a “huge, unregulated, natural experiment”