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

Prediction markets now allow betting on clinical trial results, FDA decisions
It’s a high-risk bet: Insider trading, equipoise, integrity of research, public trust are at stake

Prediction market exchanges have allowed the public to bet on the ousting of Nicolás Maduro, the outcome of the Spain v. Argentina World Cup final, and whether Trump will use the word “hippopotamus” in the month of July.

Enfortumab vedotin + pembrolizumab improves survival and reduces recurrence risk in muscle-invasive bladder cancer, phase III trial finds

Researchers have found that a combination of enfortumab vedotin and pembrolizumab helps patients with muscle-invasive bladder cancer live longer while reducing the risk that their cancer will return after surgery, according to the results of an international phase III clinical trial.

July 31, 2026

Vol.52 No.30

Drugs & Targets

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

Clinical Roundup

Tecvayli + Talvey, Talvey + pomalidomide show significant survival benefit in earlier-line r/r MM, phase III trial shows

Two drug combinations, Tecvayli (teclistamab-cqyv) + Talvey (talquetamab-tgvs), a BCMA and GPRC5D dual antigen targeting regimen, and Talvey + pomalidomide (Pomalyst, sponsored by Bristol Myers Squibb), demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival compared with investigator’s choice standard of care for adult patients with relapsed or refractory multiple myeloma who received 1 to 4 prior lines of therapy, including an anti-CD38 antibody and lenalidomide.

July 24, 2026

Vol.52 No.29

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

YOU MAY BE INTERESTED IN

Prediction markets now allow betting on clinical trial results, FDA decisions
It’s a high-risk bet: Insider trading, equipoise, integrity of research, public trust are at stake

Enfortumab vedotin + pembrolizumab improves survival and reduces recurrence risk in muscle-invasive bladder cancer, phase III trial finds

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”

Tecvayli + Talvey, Talvey + pomalidomide show significant survival benefit in earlier-line r/r MM, phase III trial shows

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

YOU MAY BE INTERESTED IN

Prediction markets now allow betting on clinical trial results, FDA decisionsIt’s a high-risk bet: Insider trading, equipoise, integrity of research, public trust are at stake

Enfortumab vedotin + pembrolizumab improves survival and reduces recurrence risk in muscle-invasive bladder cancer, phase III trial finds

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”

Tecvayli + Talvey, Talvey + pomalidomide show significant survival benefit in earlier-line r/r MM, phase III trial shows

Never miss an issue!

Login

Prediction markets now allow betting on clinical trial results, FDA decisions
It’s a high-risk bet: Insider trading, equipoise, integrity of research, public trust are at stake

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”