FDA advances rare disease drug development with new evidence principles

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

Capitol Hill

Spending bill passed by the House gives NIH $415M raise, NCI gets $128M
Legislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched

The U.S. House of Representatives Jan. 22 passed a three-bill minibus package that is expected to be the grand finale of the drama of the fiscal year 2026 appropriations process. The package, which funds the HHS as well as the departments of Defense, Transportation, Housing and Urban Development, Labor, and Education, gives NIH and NCI modest raises over FY25, and nullifies several aggressive cuts the White House had proposed for NIH.

Fifth time’s a charm? Mikaela Naylon Give Kids a Chance Act is included in FY26 spending bill

Sometime next week, the Senate is expected to vote on a legislative package that would determine the fiscal year 2026 spending levels for much of the federal government. xxx:moreReaders of The Cancer Letter may be breathing a sigh of relief that NIH seems like

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

FDA has issued a draft guidance for industry that provides recommendations to sponsors about using minimal residual disease and complete response as primary endpoints in trials evaluating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

January 16, 2026

Vol.52 No.02

By Sara Willa Ernst

FDA advances rare disease drug development with new evidence principles

YOU MAY BE INTERESTED IN

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

Spending bill passed by the House gives NIH $415M raise, NCI gets $128M
Legislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched

Fifth time’s a charm? Mikaela Naylon Give Kids a Chance Act is included in FY26 spending bill

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

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FDA advances rare disease drug development with new evidence principles

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

Spending bill passed by the House gives NIH $415M raise, NCI gets $128MLegislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched

Fifth time’s a charm? Mikaela Naylon Give Kids a Chance Act is included in FY26 spending bill

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

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

Spending bill passed by the House gives NIH $415M raise, NCI gets $128M
Legislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched

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