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.
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Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.