Regulatory News CBER Director Vinay Prasad sidelined staff to jettison Moderna’s mRNA flu shot February 13, 2026Vol.52 No.06By Claire Marie Porter
Cancer Policy FDA approves labeling changes to menopausal hormone therapy products February 13, 2026Vol.52 No.06By Claire Marie Porter
Drugs & Targets FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma February 13, 2026Vol.52 No.06
Drugs & Targets FDA approves companion diagnostic for pembrolizumab for ovarian cancer February 13, 2026Vol.52 No.06
Cancer Policy FDA debuts precheck manufacturing program to boost domestic drug development February 06, 2026Vol.52 No.05By Claire Marie Porter
Drugs & Targets FDA issues a boxed warning for capecitabine and fluorouracil on risks associated with DPD deficiency February 06, 2026Vol.52 No.05
Cancer Policy FDA delays drug reviews in new voucher program amid safety, efficacy concerns January 30, 2026Vol.52 No.04By Claire Marie Porter
Drugs & Targets FDA approves Darzalex Faspro as quad regimen for all newly diagnosed MM January 30, 2026Vol.52 No.04
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Drugs & Targets FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval January 23, 2026Vol.52 No.03
