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FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

FDA has issued a draft guidance for industry that provides recommendations to sponsors about using minimal residual disease and complete response as primary endpoints in trials evaluating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.

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

Cancer Policy

Merck & Co. drug for treating NSCLC awarded FDA priority voucher

FDA has granted sacituzumab tirumotecan (sac-TMT), a trophoblast cell-surface antigen 2 directed antibody-drug conjugate, a priority voucher via the agency’s Commissioner’s National Priority Voucher (CNPV) Pilot Program.

January 09, 2026

Vol.52 No.1

By Claire Marie Porter

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

YOU MAY BE INTERESTED IN

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

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

Merck & Co. drug for treating NSCLC awarded FDA priority voucher

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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

YOU MAY BE INTERESTED IN

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

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

Merck & Co. drug for treating NSCLC awarded FDA priority voucher

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