FDA
5 FDA decisions to watch in Q4 2026
The third quarter of 2026 brought stability to the FDA under acting commissioner Kyle Diamantas, with advisory committees resuming and permanent directors appointed at CDER and CBER. However, the confirmation of White House policy aide Heidi Overton as commissioner remains uncertain due to a tight Senate window before the midterms. In the fourth quarter, critical decisions are expected on a first-of-its-kind cancer immunotherapy, a functional cure for hepatitis B, and other notable products. This article outlines five key FDA decisions to watch.

The third quarter of 2026 brought some much-needed stability atop the Food and Drug Administration.
Acting commissioner Kyle Diamantas steered the organization through a relatively drama-free three months. Advisory committee meetings — the public drug-debate forums that had largely disappeared during former chief Marty Makary’s turbulent tenure — picked up again. And interim leaders at the FDA’s two main “CDER” and CBER drug review offices became permanent directors, giving the biopharmaceutical sector the kind of predictability it had craved for much of the previous year.
Yet still unclear is when the agency’s top position will be filled. White House policy aide Heidi Overton is President Donald Trump’s pick to be the next FDA commissioner and, at a congressional hearing last week, carefully answered thorny questions on vaccines and abortion. But her chances of being confirmed ahead the midterms are uncertain, as there’s an “extremely tight” window before the Senate hits a recess on Oct. 5, wrote RBC Capital Markets analyst Brian Abrahams.
The situation could get complicated if it drags on. A vote during “lame duck sessions” could draw resistance from moderate Republications, and a Democrat-controlled Senate might dim Overton’s chances even more, Abrahams wrote.
In the meantime, critical decisions lay ahead on a first-of-its-kind cancer immunotherapy, a “functional cure” for hepatitis B and much more. Here are five notable ones that could come during the fourth quarter.