FDA approves cabozantinib for patients 12 and up with pNET and epNET

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

Immunity against CMV leveraged against pancreatic cancer in study by UCSD, La Jolla Institute of Immunology

Researchers at the University of California San Diego and La Jolla Institute of Immunology have discovered a promising treatment approach for pancreatic cancer, one of the deadliest and most treatment-resistant forms of cancer. The approach leverages the body’s natural immune response to cytomegalovirus, a common but typically harmless virus that most people are infected with at some point in their lives.

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