News|Articles|May 1, 2026

FDA Oncology News: April 2026 Approvals, NDAs, and Priority Reviews

Explore the April 2026 FDA oncology roundup: full approval for brexu-cel in MCL, priority reviews for I-DXd and zanidatamab, and key lung cancer NDA news.

The past month saw significant regulatory activity across solid tumors and hematologic malignancies, including a transition to full approval for a chimeric antigen receptor (CAR) T-cell therapy, several new drug application (NDA) acceptances for targeted agents, and review extensions for highly anticipated delivery methods and cell therapies. Here are the top happenings from the FDA in oncology in April 2026.