发布时间：2026-07-01 13:13 Galderma received a Complete Response Letter from the FDA with comments related to observations during manufacturing site inspection and analytical method optimization
Relfydess is approved in 33 markets and already launched in more than 20, including across Europe, the Middle East and Australia, with an encouraging early launch trajectory supported by positive healthcare professional feedback
Regulatory filings in other territories are ongoing and remain on track
Ad hoc announcement pursuant to Art. 53 LR



ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD) today provided progress updates regarding the regulatory review of its pending Biologics License Application (“BLA”) for RelabotulinumtoxinA with the U.S. Food and Drug Administration (“FDA”). The Company has received a Complete Response Letter (CRL) from the FDA with comments related to observations during manufacturing site inspection and analytical method
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