India, July 31 -- 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 news...