FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

A story is told that after first obtaining approval for marketing Premarin in 1942, Wyeth Laboratories didn’t lock up the secret recipe for making the hormonal drug in a company safe, to be guarded by patent lawyers.

January 23, 2026

Vol.52 No.03

By Claire Marie Porter

Drugs & Targets

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

FDA has issued a draft guidance for industry that provides recommendations to sponsors about using minimal residual disease and complete response as primary endpoints in trials evaluating drugs and biologics intended to treat patients with multiple myeloma to support approval under the accelerated approval regulations.

January 23, 2026

Vol.52 No.03

Guest Editorial

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

FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

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Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

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

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FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

YOU MAY BE INTERESTED IN

Premarin’s 84-year hold on the market ends as FDA approves a generic versionTrade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

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

Never miss an issue!

Login

Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

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