As we head into August, it's time for our monthly roundup of the upcoming FDA decisions that could move biotech stocks.
The August regulatory calendar spans a wide range of indications - from the ultra-rare Fibrodysplasia Ossificans Progressiva (FOP) to melanoma, Alzheimer's disease, multiple myeloma, Duchenne muscular dystrophy (DMD), Glycogen Storage Disease, HIV, and essential thrombocythemia.
The FDA's approval momentum has remained strong in 2026, with 29 novel drugs approved so far - well ahead of the 21 approvals recorded during the same time frame in 2025. Last year, a total of 46 novel drugs were approved.
Before we turn to the FDA decisions scheduled for August, let's take a quick look at some of the most newsworthy developments on the regulatory front.
July 1 marked a historic first as the FDA approved Vertex Pharmaceuticals' Casgevy, making it the first gene therapy approved for young children with sickle cell disease.
Another milestone followed on July 17, when the FDA approved Merck's Lipfendra, the first oral PCSK9 inhibitor, expanding treatment options for adults with hypercholesterolemia.
The month's string of firsts continued on July 29, with the FDA licensing Ezplaz Freeze-Dried Plasma (FDP) - the first freeze-dried plasma product approved for use in the United States. Ezplaz is indicated for transfusion in adult patients who require plasma when conventional plasma products are unavailable.
Now, let's take a look at the companies awaiting FDA decisions in August.
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Business News
September 11, 2026 16:26 ET Consumer prices data was the main news on the economic front in the U.S. this week. In Europe, the latest interest rate decision from the European Central Bank was the focus along with the revised second quarter economic growth data for the euro area. In Asia, the monthly foreign trade data from China drew attention.