So far in 2025, from January through November, 39 novel drugs have been approved in the U.S., just short of the 43 approvals seen during the same period last year. Over the full year of 2024, the FDA approved 50 novel drugs, matching the total from 2021 and making it the fourth-highest approval year. The highest number of novel drug approvals occurred in 2018, with 59, followed by 55 in 2023 and 53 in 2020.
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.
As we head into September, the final month of the third quarter, it's time to take a closer look at the biotech and pharmaceutical companies with drug candidates awaiting FDA decisions.
April is recognized for various health awareness campaigns, and one of them is Autism Awareness Month. According to the most recent data from the CDC, approximately 1 in 36 children are diagnosed with autism spectrum disorder (ASD), a neurodevelopmental condition marked by difficulties in social interaction, communication, and repetitive behaviors. Currently, there are only two FDA-approved medications—Aripiprazole and Risperidone—that are used to manage certain behavioral symptoms associated with ASD.
The FDA has approved five novel drugs so far this year. Now, let’s take a look at the stocks awaiting FDA decisions in March—decisions that could not only influence stock prices but also bring hope to patients suffering from diseases with no approved treatments.