Drug Watch

FDA accepts BLA for tralokinumab for atopic dermatitis
July 09, 2020

The U.S. Food and Drug administration has accepted the Biologics License Application for tralokinumab (LEO Pharma) for moderate-to-severe atopic dermatitis and is expected to make a decision in the second quarter of 2021.

First injectable for cellulite approved by FDA
July 08, 2020

The U.S. FDA has approved collagenase clostridium histolyticum-aaes (Qwo, Endo International), making it the first FDA-approved injectable treatment for moderate-to-severe cellulite in the buttocks in adult women.

Dupilumab pre-filled pen approved by FDA
June 29, 2020

The 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 29, 2020

Almirall 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

Weekly Roundup: June 22-26
June 26, 2020

ICYMI, this week’s edition features a video series on social media use in dermatology, the launch of our new podcast, as well as articles about FDA approvals for acne and cSCC, progress in epidermolysis bullosa, new rosacea management treatment, plus more.

FDA approves Aleor’s adapalene gel for acne vulgaris
June 26, 2020

The 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.