MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy “Because it works in one neural system, you begin to wonder: Well, what about another?”

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

Nearly two years after FDA issued a final rule requiring radiologists to tell women whether their breasts are “dense” or “not dense” after a mammogram, the notification has become nearly universal.

October 02, 2026

Vol.52 No.36

By Claire Marie Porter

Drugs & Targets

FDA approves Degevma, a biosimilar for cancer-related bone complications

FDA approved Degevma (denosumab-adet) as a biosimilar to Xgeva (denosumab).

October 02, 2026

Vol.52 No.36

Drugs & Targets

FDA approves Ponlimsi, a biosimilar for preventing fractures in prostate and breast cancer patients

FDA approved Ponlimsi (denosumab-adet) as a biosimilar to Prolia.

October 02, 2026

Vol.52 No.36

Drugs & Targets

FDA accepts NDA and grants Priority Review to Lynkuet for vasomotor symptoms due to endocrine therapy in breast cancer

FDA accepted the company’s supplemental New Drug Application and granted Priority Review designation for Lynkuet (elinzanetant) under investigation for the treatment of moderate to severe vasomotor symptoms (also known as hot flashes) in women receiving endocrine therapy for treatment of breast cancer.

October 02, 2026

Vol.52 No.36

Podcast

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

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy

“Because it works in one neural system, you begin to wonder: Well, what about another?”

YOU MAY BE INTERESTED IN

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

FDA approves Degevma, a biosimilar for cancer-related bone complications

FDA approves Ponlimsi, a biosimilar for preventing fractures in prostate and breast cancer patients

FDA accepts NDA and grants Priority Review to Lynkuet for vasomotor symptoms due to endocrine therapy in breast cancer

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

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MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy

“Because it works in one neural system, you begin to wonder: Well, what about another?”

YOU MAY BE INTERESTED IN

Two years after FDA’s breast density notification rule, there is still no standard for follow-upSo far, 38 million patients have received a dense breast notification. Now what?

FDA approves Degevma, a biosimilar for cancer-related bone complications

FDA approves Ponlimsi, a biosimilar for preventing fractures in prostate and breast cancer patients

FDA accepts NDA and grants Priority Review to Lynkuet for vasomotor symptoms due to endocrine therapy in breast cancer

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

Never miss an issue!

Login

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

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