The FDA has accepted the New Drug Application (NDA) from Journey Medical Corp. for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. The FDA has set a Prescription Drug User...
Bimzelx® (bimekizumab-bkzx) from UCB is now under FDA review for a total of four potential new indications. Supplemental biologics license applications (sBLA) were submitted in February for three spondyloarthritides indications: psoriatic arthritis (PsA),...
What’s the difference between primary and secondary failure of a biologic? And why does it matter? Exploring an actual patient case, faculty from the DEF Biologic and Small Molecule NP/PA CME Bootcamp—April Armstrong, MD, MPH; David E. Cohen, MD, MPH; Kara Gooding,...
The Phase III clinical trial is now underway to evaluate fatty acid synthase (FASN) inhibitor ASC40 (Denifanstat) from Ascletis Pharma, Inc. for treatment of moderate to severe acne vulgaris. The randomized, double-blind, placebo-controlled, multicenter clinical trial...
Cosentyx® (secukinumab) from Novartis is now approved to treat moderate to severe hidradenitis suppurativa (HS) in adults. Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the...
Kristine Kucera, PA-C, MPAS, DHS The World Health Organization declared October 10 Mental Health Day. With this, they acknowledged the hidden burdens of skin disease. A large survey focused on patients suffering from dermatological conditions showed that mental...