Nicole Gormley named acting associate director for oncology endpoint development at FDA’s OCE

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

Drugs & Targets

FDA approves Jideytro for previously treated ROS1-positive non-small cell lung cancer

FDA approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received a prior ROS1 kinase inhibitor.

July 24, 2026

Vol.52 No.29

Drugs & Targets

FDA grants priority review for Talzenna + Xtandi combo in earlier prostate cancer

FDA accepted for Priority Review a supplemental New Drug Application for Talzenna (talazoparib), an oral poly ADP-ribose polymerase inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor, in men with homologous recombination repair gene-altered metastatic castration-sensitive prostate cancer, also known as metastatic hormone-sensitive prostate cancer.

July 24, 2026

Vol.52 No.29

Nicole Gormley named acting associate director for oncology endpoint development at FDA’s OCE

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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”

FDA approves Jideytro for previously treated ROS1-positive non-small cell lung cancer

FDA grants priority review for Talzenna + Xtandi combo in earlier prostate cancer

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Nicole Gormley named acting associate director for oncology endpoint development at FDA’s OCE

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”

FDA approves Jideytro for previously treated ROS1-positive non-small cell lung cancer

FDA grants priority review for Talzenna + Xtandi combo in earlier prostate cancer

Never miss an issue!

Login

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”