Galderma today announced that AKLIEF® (trifarotene 50 mcg/g cream) has concluded its European decentralised procedure resulting in the approval of its summary of product characteristics, package leaflet, and labelling, by all involved European member states. Each of the 16 concerned member states will now issue individual national marketing authorisations for the cutaneous treatment of acne vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present. Once approved, trifarotene 50 mcg/g cream will be the first new retinoid molecule launched in the European Union in 25 years.1
Galderma’s acne cream AKLIEF (trifarotene 50 mcg) has received approval by the European Union after reviewing its summary of product characteristics, package leaflet and labelling.
Galderma, a global leader in skin health focused on developing innovative aesthetic solutions, continues its strong investment in products and research that advance the aesthetics industry with seven new clinical studies recently initiated.
LAUSANNE, Switzerland--(BUSINESS WIRE)--Galderma, a global leader focused on meeting the world's increasing skin health needs, announced that it has enrolled the first patients in a new Phase 3 clinical study with nemolizumab, an investigational therapy in adult patients with moderate-to-severe atopic dermatitis.
LAUSANNE, Switzerland, Oct. 9, 2019 /PRNewswire/ -- Galderma, a global leader in skin health focused on developing innovative aesthetic solutions, recently announced the Phase 2 clinical trial results for its novel ready-to-use investigational botulinum toxin, QM1114. The multicenter, randomized, double-blind, placebo-controlled study successfully demonstrated the safety and efficacy of Galderma's liquid formulation of botulinum toxin type A for the treatment of glabellar lines (frown lines). The Phase 3 clinical trial program will begin soon to support regulatory submissions globally.
Galderma, a global leader focused on meeting the world's increasing skin health needs, announced today that the U.S. Food and Drug Administration (FDA) approved AKLIEF® (trifarotene) Cream, 0.005% for the topical treatment of acne. AKLIEF Cream is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.1,2,3 Trifarotene is the first new retinoid molecule to receive U.S. FDA approval for the treatment of acne in more than 20 years.4,5,6 AKLIEF Cream is the first topical treatment specifically studied and proven to treat both facial (forehead, cheeks, nose and chin) and truncal (chest, shoulders and back) acne, offering healthcare professionals and acne patients another treatment option.1
LAUSANNE, Switzerland--(BUSINESS WIRE)--Galderma, Nestlé Skin Health’s medical solutions business, presented the final results from a Phase 2b dose-ranging study of nemolizumab, an investigational therapy in adult patients with moderate-to-severe atopic dermatitis (AD), at the late-breaking session of the 2019 American Academy of Dermatology annual meeting (March 1-5).
Soolantra® ( (ivermectin): GALDERMA LABORATORIES, L.P.,nGALDERMA S.A., andnNESTLÉ SKIN HEALTH S.A., v.ACTAVIS LABORATORIES UT, INC.,nTEVA PHARMACEUTICALS USA,nINC., and TEVA PHARMACEUTICALnINDUSTRIES LTD.,
Soolantra® (ivermectin): Galderma Laboratories, v. Perrigo UK FINCO
Soolantra® (Ivermectin): Galderma Laboratories,Nestle Skin Health & Actavis & TevanInc.