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The Cancer Letter
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Drugs & Targets

FDA approves companion diagnostic for pembrolizumab for ovarian cancer

February 13, 2026
Vol.52 No.06
FDA debuts precheck manufacturing program to boost domestic drug development
Cancer Policy

FDA debuts precheck manufacturing program to boost domestic drug development

February 06, 2026
Vol.52 No.05
By Claire Marie Porter
Drugs & Targets

FDA issues a boxed warning for capecitabine and fluorouracil on risks associated with DPD deficiency

February 06, 2026
Vol.52 No.05
Cancer Policy

FDA delays drug reviews in new voucher program amid safety, efficacy concerns

January 30, 2026
Vol.52 No.04
By Claire Marie Porter
Drugs & Targets

FDA approves Darzalex Faspro as quad regimen for all newly diagnosed MM

January 30, 2026
Vol.52 No.04
Premarin’s 84-year hold on the market ends as FDA approves a generic version

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

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FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

January 23, 2026
Vol.52 No.03
When “safe and effective” is not “reasonable and necessary”
FreeGuest Editorial

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

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

January 16, 2026
Vol.52 No.02
By Sara Willa Ernst
FDA to increase regulatory flexibility for development of cell and gene therapies
Cancer Policy

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

January 16, 2026
Vol.52 No.02
By Jacquelyn Cobb

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