FDA grants Hernexeo Breakthrough Therapy designation as first line use for HER2-mutant advanced NSCLC

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

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

October 02, 2026

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

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

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

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.

September 25, 2026

Vol.52 No.35

By Raja M. Flores

FDA grants Hernexeo Breakthrough Therapy designation as first line use for HER2-mutant advanced NSCLC

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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

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

Renew today!

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FDA grants Hernexeo Breakthrough Therapy designation as first line use for HER2-mutant advanced NSCLC

YOU MAY BE INTERESTED IN

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

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

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