Galderma receives FDA complete response letter for anti-wrinkle neuromodulator

Galderma has been issued a complete response letter by the U.S. Food and Drug Administration for its experimental anti-wrinkle product relabotulinumtoxinA, which was under review as a neuromodulator.

The FDA letter signals that the agency has identified deficiencies that must be resolved before the drug can proceed, marking a setback for Galderma's plans to broaden its aesthetic offerings.

Separately, contract manufacturing organization Kimball announced it is acquiring a CDMO facility for $103 million, underscoring ongoing investment in manufacturing capacity despite the regulatory challenge faced by Galderma.