FDA cracks down on direct-to-consumer ads, including the Hims & Hers Superbowl blitz

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

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

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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.

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Vol.52 No.35

By Claire Marie Porter

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FDA approves Lyrfigtu for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma

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September 25, 2026

Vol.52 No.35

FDA cracks down on direct-to-consumer ads, including the Hims & Hers Superbowl blitz

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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”?

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FDA cracks down on direct-to-consumer ads, including the Hims & Hers Superbowl blitz

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

FDA approves Lyrfigtu for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma

Never miss an issue!

Login

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