The United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) resubmission for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults

RelabotulinumtoxinA is designed to optimize molecule integrity to deliver fast onset of action as early as Day 1 and sustained results for six months for frown lines and crow’s feet and has been approved in over 20 markets, including in the European Union[1-3]
News provided by
Galderma  Swiss Stock Exchange GALD
Feb. 02, 2026 15:13

ZUG, SWITZERLAND -- Galderma (SIX: GALD) today announced that the U.S. FDA has accepted the BLA resubmission for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults. Galderma has worked closely with the U.S. FDA to implement adjustments to its manufacturing process. Galderma is committed to using its expertise and heritage in the neuromodulator space to develop next-generation aesthetic solutions that address evolving needs.

“We pioneered the development of RelabotulinumtoxinA to address the growing demand for faster-acting and longer-lasting anti-wrinkle solutions. We’re excited about the potential to bring this innovative neuromodulator to the U.S., offering advanced performance and ease of use and building on our portfolio of neuromodulators that meets the full spectrum of injector and patient needs.”

BALDO SCASSELLATI SFORZOLINI, M.D., PH.D.
GLOBAL HEAD OF R&D
GALDERMA

The filing is based on data from the robust, large-scale READY (REelabotulinumtoxin Aesthetic Development StudY) clinical trial program, which is composed of four phase III trials, enrolling more than 1,900 participants.[1-4] Results demonstrated that RelabotulinumtoxinA delivered a fast onset of action as early as Day 1 and sustained results for six months for both frown lines and crow’s feet.[1,2]

RelabotulinumtoxinA (Relfydess™) has been approved in over 20 markets for the treatment of frown lines and crow’s feet, including in the European Union, the United Kingdom, Asia, and Australia. Regulatory applications are continuing to be submitted and assessed by additional authorities globally.