Galderma has received a Complete Response Letter (CRL) from the FDA for Relfydess (relbotulinumtoxinA), its novel botulinum toxin formulation intended as a Botox alternative. The CRL indicates the agency requires additional data or clarification before approval can be granted, effectively blocking the product's U.S. market entry in the near term.
Regulatory
Galderma Receives Complete Response Letter for Relfydess — Botox Rival Faces Regulatory Hurdle
FDA rejects Galderma's new neuromodulator formulation; shares slide on failed market-entry bid.
