Biotech Stocks Facing FDA Decision In October 2025

(RTTNews) - September was marked by a couple of notable firsts on the regulatory front.

On September 25, the FDA authorized the marketing of Essilor Stellest eyeglass lenses - the first approved to slow the progression of myopia in children aged 6 to 12. Myopia, or near-sightedness, is a chronic condition affecting roughly 40% of the U.S. population, with rates rising rapidly among children and adolescents.

Just days earlier, on September 19, the FDA granted accelerated approval to Stealth Biotherapeutics' Forzinity, which becomes the first-ever treatment for the life-threatening mitochondrial disorder, Barth syndrome.

Meanwhile, the most commonly used analgesic, acetaminophen (Tylenol), found itself under renewed scrutiny, as the FDA, on September 22, initiated the process of updating its labeling to warn of the potential association between acetaminophen use during pregnancy and an increased risk of autism and ADHD in children.

Let us now shift our attention to take a look at the drugs currently awaiting FDA approval decisions in October.