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FDA approves guselkumab for psoriatic arthritis
July 16th 2020Guselkumab becomes the first IL-23 inhibitor approved for treatment of psoriatic arthritis by the U.S. Food and Drug Administration (FDA) following positive phase 3 results from two trials investigating the safety and efficacy of the drug.
Dupilumab pre-filled pen approved by FDA
June 29th 2020The U.S. Food and Drug Administration has approved a single-dose 300 mg pre-filled pen version of dupilumab (Dupixent, Sanofi and Regeneron) for the treatment of atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP) in U.S. patients 12 years and older.
FDA approves new label for sarecycline
June 29th 2020Almirall announces the U.S. Food and Drug Administration has approved the updated label for their oral antibiotic sarecycline (Seysara) for treatment of acne vulgaris to help promote the appropriate use of the drug to aid in preventing antimicrobial resistance commonly warned when using antibiotics
FDA approves Aleor’s adapalene gel for acne vulgaris
June 26th 2020The U.S. Food and Drug Administration has approved the Abbreviated New Drug Application for topical retinoid adapalene gel USP, 0.3% from Alembic Pharmaceuticals and its joint venture Aleor Dermaceuticals for treatment of acne vulgaris.
Tazarotene topical for acne vulgaris launches in United States
June 25th 2020Tazarotene lotion 0.045% (Arazlo, Ortho Dermatologics) is officially launched in the U.S. following approval by the U.S. Food and Drug Administration in late 2019 for the treatment of acne vulgaris in patients 9 years and older.