Galderma announced that the U.S. Food and Drug Administration has accepted the resubmission of its Biologics License Application (BLA) for RelabotulinumtoxinA, a next-generation neuromodulator designed to treat moderate-to-severe frown lines and crow’s feet. The regulatory milestone signals that the company has addressed prior manufacturing-related concerns and brings the product one step closer to potential approval for use in U.S. medical aesthetic practices. 

On February 2, 2026, Galderma confirmed that the FDA accepted its resubmitted BLA for RelabotulinumtoxinA for the temporary improvement of glabellar lines and lateral canthal lines in adults. The acceptance follows a Complete Response Letter (CRL) issued in 2023 that cited deficiencies limited to chemistry, manufacturing, and controls (CMC), rather than safety or efficacy concerns. Galderma stated that it worked closely with the FDA to implement manufacturing process adjustments before resubmitting the application.

FDA BLA acceptance does not equal approval, but it does indicate that the application is sufficiently complete for substantive review. The agency will now evaluate whether the updated manufacturing information meets regulatory standards, with a review timeline that will depend on whether the resubmission is classified as Class 1 or Class 2. 

The BLA is supported by Galderma’s READY (RElabotulinumtoxin Aesthetic Development StudY) clinical trial program, which includes four phase III studies enrolling more than 1,900 participants. According to the company, trial results demonstrated a rapid onset of action, with visible improvements as early as day one, and sustained aesthetic results lasting up to six months for both frown lines and crow’s feet. 

RelabotulinumtoxinA, branded as Relfydess in other markets, is positioned as a ready-to-use liquid neuromodulator. Unlike traditional botulinum toxin products that require reconstitution, RelabotulinumtoxinA is designed for volumetric dosing and is manufactured using Galderma’s proprietary PEARL technology to help preserve molecular integrity. This formulation aims to improve consistency, ease of use, and workflow efficiency for injectors. 

“We pioneered the development of RelabotulinumtoxinA to address the growing demand for faster-acting and longer-lasting anti-wrinkle solutions,” said Baldo Scassellati Sforzolini, MD, PhD, global head of R&D at Galderma. “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.”