In the era of immunotherapy and targeted therapies, ODAC focuses on dose optimization in children

The Galleri MCD vote: What FDA asked its advisors to ignore

In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, Jacquelyn Cobb, managing editor, discuss the Sept. 23 meeting of the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, during which the panel voted in favor of Galleri, the multi-cancer detection test from GRAIL Inc., to become the first multi-cancer detection test to receive regulatory approval.

September 30, 2026

News Analysis Regulatory News

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says

The FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted in favor of Galleri to become the first multi-cancer detection test to receive regulatory approval.

September 25, 2026

Vol.52 No.35

By Jacquelyn Cobb and Sara Willa Ernst

Perspective

When did stage 3B lung cancer become “early stage”?

My recent column about Merck’s television commercial for perioperative Keytruda left me with a question I could not shake.

At confirmation hearing, Heidi Overton sidesteps questions about FDA regulation of fruit-flavored vapes

Heidi Overton, President Trump’s nominee for FDA Commissioner, defended the agency’s recent policy decisions reversing its hardball stance on flavored nicotine products, as she appeared in front of the Senate Committee on Health, Education, Labor, and Pensions on Sept 24.

HHS issues direct final rule to reduce reliance on animal testing

FDA has issued a direct final rule that changes the language in its regulations so that “animal testing” is no longer described as the default or defining form of “nonclinical” safety testing.

September 25, 2026

Vol.52 No.35

By Claire Marie Porter

In Brief

Ronald McDonald Community Floor opens in honor of Childhood Cancer Awareness Month

Ronald McDonald House New York announced the completion of its renovation of the Community Floor, a reimagined space designed to enhance the everyday experience of children and families staying at the House while their children receive treatment for serious illnesses. The project, which has transformed dining, kitchen, play, and program areas on the second floor of the House at 405 East 73rd Street, creates spaces where families can share meals, children can play and learn, and caregivers can find opportunities for connection, respite, and support.

September 25, 2026

Vol.52 No.35

In the era of immunotherapy and targeted therapies, ODAC focuses on dose optimization in children

YOU MAY BE INTERESTED IN

The Galleri MCD vote: What FDA asked its advisors to ignore

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says

When did stage 3B lung cancer become “early stage”?

At confirmation hearing, Heidi Overton sidesteps questions about FDA regulation of fruit-flavored vapes

HHS issues direct final rule to reduce reliance on animal testing

Ronald McDonald Community Floor opens in honor of Childhood Cancer Awareness Month

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In the era of immunotherapy and targeted therapies, ODAC focuses on dose optimization in children

YOU MAY BE INTERESTED IN

The Galleri MCD vote: What FDA asked its advisors to ignore

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claimsClinical benefit will not be considered for approval, FDA says

When did stage 3B lung cancer become “early stage”?

At confirmation hearing, Heidi Overton sidesteps questions about FDA regulation of fruit-flavored vapes

HHS issues direct final rule to reduce reliance on animal testing

Ronald McDonald Community Floor opens in honor of Childhood Cancer Awareness Month

Never miss an issue!

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FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says