ODAC votes to recommend neuroblastoma drug for first-ever approval based on trial using external control arm

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

Podcast

How will FDA regulate psychedelics?

FDA has been taking a look at psychedelics as a potential treatment for psychiatric and substance abuse disorders, recently publishing a final guidance for drug sponsors conducting clinical trials of psychedelics, including psilocybin, LSD, and MDMA.

July 22, 2026

Vol.52 No.28

Regulatory News

FDA final guidance on psychedelics opens the door to psycho-oncology research
Guidance permits treatment without psychotherapy, alarming scientists, advocates

FDA has released a final guidance for drug sponsors conducting clinical trials of psychedelics, including psilocybin, LSD, and MDMA, for the treatment of psychiatric and substance abuse disorders.

House Energy & Commerce hearing focuses on America’s leadership in biomedical research, examines FDA role

At a recent House Energy and Commerce Health Subcommittee hearing titled “Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role in Advancing U.S. Drug Development,” lawmakers examined ways to increase efficiency and speed across early-stage clinical trial development.

July 17, 2026

Vol.52 No.28

By Claire Marie Porter

ODAC votes to recommend neuroblastoma drug for first-ever approval based on trial using external control arm

YOU MAY BE INTERESTED IN

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

How will FDA regulate psychedelics?

FDA final guidance on psychedelics opens the door to psycho-oncology research
Guidance permits treatment without psychotherapy, alarming scientists, advocates

House Energy & Commerce hearing focuses on America’s leadership in biomedical research, examines FDA role

Renew today!

Subscriber content

Never miss an issue!

Login

ODAC votes to recommend neuroblastoma drug for first-ever approval based on trial using external control arm

YOU MAY BE INTERESTED IN

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

How will FDA regulate psychedelics?

FDA final guidance on psychedelics opens the door to psycho-oncology researchGuidance permits treatment without psychotherapy, alarming scientists, advocates

House Energy & Commerce hearing focuses on America’s leadership in biomedical research, examines FDA role

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”

FDA final guidance on psychedelics opens the door to psycho-oncology research
Guidance permits treatment without psychotherapy, alarming scientists, advocates