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.
Pfizer reports positive results from second abrocitinib monotherapy study
June 4th 2020Full results from the second of two trials investigating the JAK1 inhibitor abrocitinib as a monotherapy for treatment of moderate-to-severe atopic dermatitis demonstrate statistical superiority of both doses compared to placebo.
5-year follow-up demonstrates long-term benefit of dabrafenib/trametinib for stage 3 melanoma
June 4th 2020Results presented at the recent ASCO 2020 Virtual Scientific Program demonstrate the long-term relapse-free and survival benefit of dabrafenib (Tafinlar, Novartis) and trametinib (Mekinist, Novartis) as a combination treatment following surgery in stage III BRAF V600E/K-mutant melanoma patients.