The May FDA calendar appears relatively light. The upcoming regulatory milestones include a potential label expansion of argenx SE’s VYVGART, and an additional indication for Daiichi Sankyo Company and AstraZeneca plc’s cancer therapy Enhertu, among others.
As the second quarter gets underway, April stands out for both global health awareness - from Cancer Control Month to World Health Day on April 7 - and a fresh wave of regulatory catalysts.
As we head into the final month of the first quarter, it’s time to take stock of the regulatory landscape.
The FDA approved 46 novel drugs in 2025, with 70% receiving approval in the United States before any other country, according to a report from the Center for Drug Evaluation and Research (CDER). The 2025 tally falls short of the 50 novel drug approvals recorded in 2024.
So far in 2025, 44 novel drugs have received FDA approval, compared to 50 in the prior year. Against this backdrop, we turn our attention to what lies ahead, taking a closer look at the key regulatory decisions and anticipated approvals slated for January 2026.
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.