Biotech Stocks Facing FDA Decision In July 2026

(RTTNews) - July is here, and the FDA is set to announce decisions on therapies for conditions ranging from breast cancer and IgA nephropathy to multiple myeloma, ADHD, and wet AMD.

Before turning our attention to the key FDA decisions expected in July, here are some of the newsworthy regulatory headlines of June.

For the first time in more than two decades, the FDA approved a new active ingredient for over-the-counter (OTC) sunscreens. On June 9, 2026, the U. regulator added Bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in its efforts to advance sunscreen innovation. Bemotrizinol is the first new sunscreen active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.

On June 12, 2026, the FDA cleared Dexcom's Stelo Glucose Biosensor System, making it the first over-the-counter (OTC) continuous glucose monitor (CGM) for children.

Ahead of the upcoming influenza season, the FDA approved the first generic version of Xofluza (baloxavir marboxil) tablets on June 17, 2026. The approval marks the first generic single-dose treatment for acute uncomplicated influenza and prophylaxis in patients aged five years and older.

The FDA closed out June with a landmark approval, authorizing Orca Biosystem's Tregzi, the first regulatory T (Treg) cell-based immunotherapy for reducing chronic graft-versus-host disease (GVHD) in patients with blood cancers undergoing stem cell transplantation.

Now, let's take a look at the companies awaiting FDA decisions in July.