Makary, Prasad describe FDA’s new “plausible mechanism pathway” to get bespoke therapies to market sans RCT

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

Clinical Regulatory News

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?”

For the past four decades, psilocybin research has focused on one area: the treatment of mental health disorders, including depression, anxiety, existential distress associated with serious medical illnesses, post-traumatic stress disorder, and addiction.

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

Makary, Prasad describe FDA’s new “plausible mechanism pathway” to get bespoke therapies to market sans RCT

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?

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?”

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

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Makary, Prasad describe FDA’s new “plausible mechanism pathway” to get bespoke therapies to market sans RCT

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?

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?”

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

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?

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?”