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Evolus submits Evolysse premarket approval application to FDA

Evolus (EOLS) announced that it has submitted the final module of its premarket approval application to the FDA for Evolysse Sculpt, an injectable hyaluronic acid gel product designed to restore mid-face volume. Evolus anticipates that the FDA’s review will follow the standard PMA process, with approval expected in the second half of 2026.

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