Biotech Stocks Facing FDA Decision In September 2025

(RTTNews) - 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.

September is also a month of several significant observances, including World Alzheimer's Month, Blood Cancer Awareness Month, and Childhood Cancer Awareness Month, among others.

So far this year (January through August), the FDA has approved 26 novel drugs - slightly trailing the 29 approvals recorded during the same period last year.

Now, let's explore the drug candidates currently under FDA review, with potential approvals on the horizon this September.

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