News|Articles|June 5, 2026

May 2026: FDA Oncology Actions at a Glance

Fact checked by: Sabrina Serani

FDA greenlights eight May 2026 oncology approvals, debuting first PROTAC, expanding breast ADCs, and advancing biomarker-driven bladder cancer and rare blood cancers.

May 2026 proved to be one of the most consequential months of the year for oncology regulators, with the FDA issuing 8 oncology and hematology approvals spanning breast cancer, bladder cancer, hematologic malignancies, and rare solid tumors. The month opened with a historic milestone—the first-ever FDA approval of a PROTAC (proteolysis-targeting chimera) in any indication—and closed with a novel antibody-drug conjugate for an ultra-rare blood cancer. Below is a glance at every key action from the month.