FDA Accepts Galderma’s RelabotulinumtoxinA BLA Resubmission

Key Takeaways

• The FDA has accepted Galderma’s resubmitted BLA for relabotulinumtoxinA targeting glabellar lines and crow’s feet.

• Data from the phase III READY trials showed onset as early as day 1 and durability up to 6 months.

• RelabotulinumtoxinA is currently approved in more than 20 international markets as Relfydess™.

Galderma announced that the US Food and Drug Administration (FDA) has accepted the resubmitted Biologics License Application (BLA) for relabotulinumtoxinA (Relfydess™) for the temporary improvement of moderate-to-severe glabellar lines and lateral canthal lines in adults. 

According to a press release from Galderma, the BLA is supported by data from the READY (REelabotulinumtoxin Aesthetic Development StudY) clinical trial program, a phase 3 program consisting of four randomized trials and more than 1,900 participants. RelabotulinumtoxinA demonstrated a rapid onset of effect across all trials, with visible improvements reported as early as day 1, and durability of response lasting up to 6 months for both frown lines and crow’s feet.

“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, said in the news release. “We’re excited about the potential to bring this innovative neuromodulator to the US, offering advanced performance and ease of use and building on our portfolio of neuromodulators that meets the full spectrum of injector and patient needs.”

RelabotulinumtoxinA has been approved in more than 20 markets, including the EU, the United Kingdom, parts of Asia, and Australia.

Source: Galderma press release. February 2, 2026.