REMS for currently approved BCMA- and CD19-directed autologous CAR T-cell immunotherapies eliminated

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

Clinical Roundup

Next-gen CAR-T therapy shows “dramatic and rapid” regression of glioblastoma, Mass General phase I study finds

Just days after a single treatment, patients experienced dramatic reductions in their tumors, with one patient achieving near-complete tumor regression, according to the results of a phase I study conducted by researchers at Mass General Cancer Center.

July 24, 2026

Vol.52 No.29

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.

July 17, 2026

Vol.52 No.28

By Sara Willa Ernst

REMS for currently approved BCMA- and CD19-directed autologous CAR T-cell immunotherapies eliminated

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”

Next-gen CAR-T therapy shows “dramatic and rapid” regression of glioblastoma, Mass General phase I study finds

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

Renew today!

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REMS for currently approved BCMA- and CD19-directed autologous CAR T-cell immunotherapies eliminated

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”

Next-gen CAR-T therapy shows “dramatic and rapid” regression of glioblastoma, Mass General phase I study finds

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

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