Trump et al. focus on NIH, cancer—and how peer review is done

Breaking down Operation Trailblazer: Rolling INDs, outside expert submission help, and one-trial requirement

In this week’s episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, and Sara Willa Ernst, reporter, break down HHS’ latest vision for the future: Operation Trailblazer.

July 01, 2026

Regulatory News

To keep the early clinical trial enterprise in the U.S., HHS pledges to simplify regulatory requirements

HHS earlier this week rolled out a cluster of initiatives related to simplifying clinical trials, presenting these measures as a government-wide effort to maintain America’s leadership in early-stage drug development.

OMB draft rule politicizing research should be rescinded, House Dems urge in a letter to Bhattacharya

Democratic leaders of the House Committee on Energy and Commerce are urging NIH Director Jay Bhattacharya to voice objections to a proposed rule from the Office of Management and Budget that would give the administration unprecedented political control over government-funded science.

FDA approves Tecelra for pediatric synovial sarcoma

FDA granted full approval of Tecelra (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

June 26, 2026

Vol.52 No.25

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FDA has issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for some cancer pharmaceuticals.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

Clinical Roundup

Pediatric cancer exercise guidelines recommend movement during and after treatment

Children and adolescents undergoing cancer treatment should no longer be encouraged to rest whenever possible.

June 18, 2026

Vol.52 No.24

Trump et al. focus on NIH, cancer—and how peer review is done

YOU MAY BE INTERESTED IN

Breaking down Operation Trailblazer: Rolling INDs, outside expert submission help, and one-trial requirement

To keep the early clinical trial enterprise in the U.S., HHS pledges to simplify regulatory requirements

OMB draft rule politicizing research should be rescinded, House Dems urge in a letter to Bhattacharya

FDA approves Tecelra for pediatric synovial sarcoma

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

Pediatric cancer exercise guidelines recommend movement during and after treatment

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