Galderma (GALD.S) Relfydess receives another CRL in the US, further delaying regulatory approval-20260702
高盛·2026-07-02 17:16

This morning (July 1, 2026), Galderma announced it has received another Complete Response Letter (CRL) from the FDA for Relfydess, its ready-to-use liquid, longer-acting, neuromodulator, with comments related to observations during manufacturing site inspection and analytical method optimisation. Per the release, we note the FDA conducted a pre-license inspection of Galderma's Uppsala manufacturing site, with all other aspects of its Biologics License Application, including safety and efficacy-related aspec ...

Galderma (GALD.S) Relfydess receives another CRL in the US, further delaying regulatory approval-20260702 - Reportify