FDA grants Priority Review to perioperative IMFINZI + enfortumab vedotin for muscle-invasive bladder cancer

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

Drugs & Targets

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

FDA granted approval for Lyrfigtu (lirafugratinib) as a treatment option for patients with cholangiocarcinoma with FGFR2 fusion or other rearrangement.

September 25, 2026

Vol.52 No.35

Drugs & Targets

FDA approves belzutifan in combination with lenvatinib for advanced RCC with a clear cell component

FDA has approved belzutifan (Welireg) in combination with lenvatinib (Lenvima) for adults with advanced renal cell carcinoma with a clear cell component following a programmed death receptor-1 or programmed death-ligand 1 inhibitor.

September 25, 2026

Vol.52 No.35

FDA grants Priority Review to perioperative IMFINZI + enfortumab vedotin for muscle-invasive bladder cancer

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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

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

FDA approves belzutifan in combination with lenvatinib for advanced RCC with a clear cell component

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FDA grants Priority Review to perioperative IMFINZI + enfortumab vedotin for muscle-invasive bladder cancer

YOU MAY BE INTERESTED IN

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

FDA approves belzutifan in combination with lenvatinib for advanced RCC with a clear cell component

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