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Vol.52 No.35

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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.

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In a 6-6 vote, ODAC says “maybe” to Sutent for adjuvant kidney cancer—

But at FDA “Maybe” has meaning

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Renew today!

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In a 6-6 vote, ODAC says “maybe” to Sutent for adjuvant kidney cancer—

But at FDA “Maybe” has meaning

YOU MAY BE INTERESTED IN

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

The Directors: Two Gulf Coast cancer center directors on why NCI designation matters—and why they want itLucio Miele and Raghu Kalluri: Science and technology have changed what an aspiring cancer center must accomplish

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

Trump weighs—and abandons—an executive order that would give OMB veto power over NIH grants

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

How biology is reshaping breast cancer care

Never miss an issue!

Login

The Directors: Two Gulf Coast cancer center directors on why NCI designation matters—and why they want it
Lucio Miele and Raghu Kalluri: Science and technology have changed what an aspiring cancer center must accomplish

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