FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

Regulatory News

Is psilocybin heading to a cancer clinic near you?
Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research

Earlier this year, Joe Rogan, host of “The Joe Rogan Experience” podcast, sent a text to President Donald Trump.

June 18, 2026

Vol.52 No.24

By Sara Willa Ernst

Clinical Trials & Tribulations

What NHS-Galleri taught us—and what it didn’t

On May 30, GRAIL reported the full results of the NHS-Galleri trial in an oral presentation at the ASCO Annual Meeting.

June 18, 2026

Vol.52 No.24

By Scott D. Ramsey and Ruth Etzioni

Clinical Trials & Tribulations

The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies

The NHS-Galleri trial presented at ASCO was the largest, prospective, randomized trial of a multicancer early detection test (MCED) to date. The study enrolled approximately 143,000 asymptomatic adults (ages 50-77) and was the first of its kind to assess clinical utility of an MCED test for cancer screening.

June 18, 2026

Vol.52 No.24

By Bryan Bassig, Catherine R. Marinac, David M. Routman, Elizabeth K. O'Donnell, Jennifer Keating Litton, Karthik V. Giridhar, Kennedy Ng Yao Yi, Kurt Giles, Nima Nabavizadeh, Ora K. Gordon, Rebecca Kaltman and Shawn Kothari

News Analysis

FDA clears a way for dramatic reduction in animal toxicology studies in cancer

FDA has issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for some cancer pharmaceuticals.

June 18, 2026

Vol.52 No.24

By Claire Marie Porter

Cancer Policy

OMB proposed rule could end 50% of currently active clinical trials, Stand up for Science analysis finds

An analysis by Stand up for Science found that the White House Office of Management and Budget’s recently proposed rule, “Regulation for Federal Financial Assistance,” if finalized, could result in termination of nearly 50% of active clinical research studies.

All-oral regimen of decitabine-cedazuridine + venetoclax yields 47% complete response rate, ASCERTAIN-V phase I/II clinical trial finds

The ASCERTAIN-V phase I/II clinical trial, which evaluated the first all-oral regimen of decitabine-cedazuridine plus venetoclax in patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive induction chemotherapy, demonstrated favorable response rates and survival with expected myelosuppressive effects.

June 18, 2026

Vol.52 No.24

FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

YOU MAY BE INTERESTED IN

Is psilocybin heading to a cancer clinic near you?
Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research

What NHS-Galleri taught us—and what it didn’t

The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies

FDA clears a way for dramatic reduction in animal toxicology studies in cancer

OMB proposed rule could end 50% of currently active clinical trials, Stand up for Science analysis finds

All-oral regimen of decitabine-cedazuridine + venetoclax yields 47% complete response rate, ASCERTAIN-V phase I/II clinical trial finds

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FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

YOU MAY BE INTERESTED IN

Is psilocybin heading to a cancer clinic near you?Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research

What NHS-Galleri taught us—and what it didn’t

The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies

FDA clears a way for dramatic reduction in animal toxicology studies in cancer

OMB proposed rule could end 50% of currently active clinical trials, Stand up for Science analysis finds

All-oral regimen of decitabine-cedazuridine + venetoclax yields 47% complete response rate, ASCERTAIN-V phase I/II clinical trial finds

Never miss an issue!

Login

Is psilocybin heading to a cancer clinic near you?
Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research