Paige’s Razik Yousfi: Biden has set expectations for AI, but details will come via federal guidelines

CBER Director Vinay Prasad sidelined staff to jettison Moderna’s mRNA flu shot

In the latest episode of Vinay Prasad’s extraordinary adventures at FDA, the agency (i.e. Dr. Prasad himself) has issued a Refusal-to-File letter to an mRNA-based influenza vaccine application.

February 13, 2026

Vol.52 No.06

By Claire Marie Porter

Cancer Policy

FDA approves labeling changes to menopausal hormone therapy products

FDA has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy.

February 13, 2026

Vol.52 No.06

By Claire Marie Porter

Clinical Roundup

AI tool may help personalize ovarian cancer treatment from day one

Researchers from the University of Minnesota Medical School, in collaboration with Emory University and the Georgia Institute of Technology, have developed a new artificial intelligence biomarker tool that may help predict how ovarian cancer patients will respond to treatment at the time of diagnosis.

February 13, 2026

Vol.52 No.06

Drugs & Targets

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

FDA approved pembrolizumab, as well as pembrolizumab and berahyaluronidase alfa-pmph in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.

February 13, 2026

Vol.52 No.06

Drugs & Targets

FDA approves companion diagnostic for pembrolizumab for ovarian cancer

FDA has approved PD-L1 IHC 22C3 pharmDx, Code SK006m as the only FDA-approved companion diagnostic indicated to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, whose tumors express PD-L1 and who may be eligible for treatment with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.

February 13, 2026

Vol.52 No.06