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 January 23, 2026Vol.52 No.03By 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Drugs & Targets FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval January 23, 2026Vol.52 No.03
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, 2026Vol.52 No.02By Mark J. Ratain and David A. Hyman
Cancer Policy FDA releases 10 guiding principles for AI use in drug development January 16, 2026Vol.52 No.02By Sara Willa Ernst
Cancer Policy FDA to increase regulatory flexibility for development of cell and gene therapies January 16, 2026Vol.52 No.02By Jacquelyn Cobb
Drugs & Targets FDA accepts NDA for pimicotinib for treatment of tenosynovial giant cell tumor January 16, 2026Vol.52 No.02
Cancer Policy Merck & Co. drug for treating NSCLC awarded FDA priority voucher January 09, 2026Vol.52 No.1By Claire Marie Porter
Cancer Policy FDA-mandated report finds “insufficient data” to determine safety of PFAS in cosmetics January 09, 2026Vol.52 No.1By Claire Marie Porter
Drugs & Targets FDA grants Enhertu Breakthrough Therapy designation as post-neoadjuvant therapy for HER2+ early breast cancer January 09, 2026Vol.52 No.1
