FDA approves Anktiva for non-muscle-invasive bladder cancer

When “safe and effective” is not “reasonable and necessary”
We can curb excessive drug dosing and improve the quality of cancer care

By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it. To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...

January 16, 2026

Vol.52 No.02

By Mark J. Ratain and David A. Hyman

Cancer Policy

FDA releases 10 guiding principles for AI use in drug development

FDA, in collaboration with the European Medicines Agency, has published 10 principles to help guide pharmaceutical companies using artificial intelligence to develop drug, biological, and medical devices.

FDA to increase regulatory flexibility for development of cell and gene therapies

FDA has released additional information on its “flexible approach” to regulating chemistry, manufacturing and control, or CMC, requirements for cell and gene therapies.

Mutation predicts chemoresistance and better responses to immunotherapy in advanced bladder cancer, MD Anderson study finds

Researchers at The University of Texas MD Anderson Cancer Center have determined that mutations in the KDM6A gene—common in advanced bladder cancer—may serve as a predictive biomarker to determine which patients are less likely to benefit from standard chemotherapy but may respond better to immunotherapy.

January 16, 2026

Vol.52 No.02

Drugs & Targets

FDA accepts NDA for pimicotinib for treatment of tenosynovial giant cell tumor

FDA accepted the new drug application for pimicotinib (ABSK021) as a systemic treatment for patients with tenosynovial giant cell tumor.

January 16, 2026

Vol.52 No.02

Composite intelligence: How AI-driven biomarkers are setting the bar in immuno-oncology

Immune-checkpoint inhibitors (ICIs) transformed treatment paradigms in dozens of malignancies, yet oncologists still confront a deceptively simple question at every consult: Will this individual patient benefit and at what cost?

January 09, 2026

Vol.52 No.1

By Ofer Sharon, Michal Harel and Yehonatan Elon

FDA approves Anktiva for non-muscle-invasive bladder cancer

YOU MAY BE INTERESTED IN

When “safe and effective” is not “reasonable and necessary”
We can curb excessive drug dosing and improve the quality of cancer care

FDA releases 10 guiding principles for AI use in drug development

FDA to increase regulatory flexibility for development of cell and gene therapies

Mutation predicts chemoresistance and better responses to immunotherapy in advanced bladder cancer, MD Anderson study finds

FDA accepts NDA for pimicotinib for treatment of tenosynovial giant cell tumor

Composite intelligence: How AI-driven biomarkers are setting the bar in immuno-oncology

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FDA approves Anktiva for non-muscle-invasive bladder cancer

YOU MAY BE INTERESTED IN

When “safe and effective” is not “reasonable and necessary”We can curb excessive drug dosing and improve the quality of cancer care

FDA releases 10 guiding principles for AI use in drug development

FDA to increase regulatory flexibility for development of cell and gene therapies

Mutation predicts chemoresistance and better responses to immunotherapy in advanced bladder cancer, MD Anderson study finds

FDA accepts NDA for pimicotinib for treatment of tenosynovial giant cell tumor

Composite intelligence: How AI-driven biomarkers are setting the bar in immuno-oncology

Never miss an issue!

Login

When “safe and effective” is not “reasonable and necessary”
We can curb excessive drug dosing and improve the quality of cancer care