Biotech Stocks Facing FDA Decision In September 2026

(RTTNews) - As September ushers in the first hints of autumn, it also brings a packed FDA regulatory calendar.

But before we turn the page to September, here's what happened on the regulatory front in August - a month marked by several notable firsts.

On August 5, 2026, the FDA approved Takeda Pharmaceutical's (TAK) Orzeyful tablets for the treatment of narcolepsy type 1 in adults, making it the first and only medicine to directly target the underlying cause of the disorder.

On August 19, the FDA authorized Aletta, the first standalone robotic device capable of drawing blood from a patient's arm without hands-on operator intervention - a development aimed at easing the growing shortage of phlebotomists.

The same day, Ultragenyx Pharmaceutical's Genglycos received accelerated FDA approval, becoming the first therapy approved for patients aged 8 years and older with glycogen storage disease type Ia.

And on August 25, the FDA authorized Abbott Diabetes Care's Libre Duo 10 Day, the first wearable device designed to continuously monitor both ketone levels and blood glucose, potentially helping people with diabetes identify warning signs of a serious complication before it develops into a medical emergency.

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