Zurich: FDA again rejects Galderma’s Relfydess application
PUBLISHED Jul 1, 2026, 11:07 AM ET
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Switzerland-based Galderma Group AG said on July 1, 2026, that the U.S. Food and Drug Administration has again declined to approve its wrinkle-treatment neuromodulator Relfydess (RelabotulinumtoxinA) for sale in the United States. The decision, delivered in a Complete Response Letter following a pre-license inspection of Galderma’s manufacturing facility, cited unresolved chemistry, manufacturing and controls deficiencies at the company’s production site. Galderma said the FDA’s observations relate solely to operational and quality systems at the plant and do not address the product’s safety, efficacy or clinical performance, which previously met primary endpoints in extensive clinical trials. The latest ruling marks the second time the FDA has blocked Relfydess from entering the U.S. aesthetic medicine market, after a 2023 rejection that highlighted similar shortcomings in manufacturing and quality control processes. Galderma said it had worked to remedy the earlier findings, but the regulator concluded that further corrective and preventive actions are still required before it can grant a license. Relfydess is seen within the industry as a key potential challenger to AbbVie’s Botox in the lucrative wrinkle-treatment segment. News of the fresh setback sent Galderma’s shares down as much as 6.6% in Zurich trading, the steepest single-day fall in more than a year.
By Michael Grant | JQJO News
Timeline of Events
- 2023 FDA rejects initial Relfydess application
- 2023 Galderma begins addressing manufacturing deficiencies
- Recent weeks FDA conducts pre-license inspection
- July 1, 2026 FDA issues Complete Response Letter
- July 1, 2026 Galderma discloses nonclinical CMC concerns
- July 1, 2026 Relfydess approval denied again
- July 1, 2026 Galderma stock drops 6.6%
- After July 1, 2026 further corrective actions required
News Intelligence
- If you're an investor in Galderma or the aesthetic medicine market, this news is crucial. The FDA's repeated rejection of Relfydess impacts Galderma's stock value and market position. Check your portfolio and consider discussing with your financial advisor.
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