Drug Watch

The FDA has granted priority review to Merck’s application for pembrolizumab, a treatment for melanoma.

UCB announced that more than 90% of patients treated with bimekizumab have maintained IGA 1/0 results in their long-term BE BRIGHT trial.

The FDA has accepted the New Drug Application (NDA) for tapinarof as a treatment for plaque psoriasis in adults and set the PDUFA target action date to Q2 2022.

Mark Lebwohl, MD, explains the recent delay in approval of JAK inhibitors by the FDA, how it is affecting the inflammatory skin disease community, and if physicians should be concerned.

The FDA has granted priority review to a supplemental biologics license application for pembrolizumab for the use as an adjuvant treatment in adult and pediatric patients with stage IIB or IIC melanoma following complete resection.

The results from the Heads Up study were published in JAMA Dermatology, which demonstrated upadacitinib was superior to dupilumab in treating atopic dermatitis.

Ritlecitinib, an investigational covalent kinase inhibitor, achieved its primary endpoint and demonstrated statistically significant efficacy compared to placebo in treating alopecia areata.

Joshua Zeichner, MD, associate professor of dermatology and director of cosmetic & clinical research in dermatology, Mount Sinai Hospital, New York, discusses the impact of the recent FDA approval of Twyneo (Sol-Gel) for the treatment of acne.

Immunotherapy agent nemvaleukin alfa was granted an FDA fast track designation for the treatment of patient’s mucosal melanoma for previously undergone treatment with an anti-PD-L1 therapy.

MediWound Ltd, announced the results for its CIDS trial studying NexoBrid as a treatment for children with severe thermal burns.

Dalbavancin has received FDA approval to treat acute bacterial skin and skin structure infections in pediatric patients.

The FDA has granted an orphan drug designation to alrizomadlin as a potential therapeutic option for patients with stage IIB-IV melanoma.

The newest FDA indication allows for greater distribution to younger but equally vulnerable immunocompromised patients.

Twyneo, a tretinoin and benzoyl peroxide cream, has been approved by the FDA for the treatment of acne vulgaris in patients 9 years and older.

BFI-751, Biofactura’s biosimilar drug to ustekinumab will be investigated for the first time on human patients.

The combination of belapectin plus pembrolizumab has demonstrated early potential for disease control with acceptable tolerability in patients with metastatic melanoma.

Sol-Gel has announced pre-clinical data on SGT-510, its roflumilast drug, for the treatment of psoriasis.

Journey Medical Corporation and Dr. Reddy’s Laboratories Ltd. have joined forces for the development and commercialization of DFD-19 as a treatment for rosacea.

Brickell BioTech, Inc announced the completion of its Cardigan I study and final enrollment of the Cardigan II study.

The FDA has expanded the label for pembrolizumab for use as a monotherapy in the treatment of patients with locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

OncoSec Medical Inc. and Merck have entered into a supply and clinical trial agreement for pembrolizumab (Keytruda) and tavokinogene telseplasmid (Tavo) for the potential treatment of late-stage metastatic melanoma.

Arcutis Biotherapeutics announced early termination of its phase 2a trial evaluating ARQ-252 as a potential treatment for vitiligo citing to inadequate local drug delivery to the skin.

Explore what dermatologic drugs the FDA will decide to approve during July 2021.

The European Commission has approved cemiplimab for the treatment of locally advanced or metastatic basal cell carcinoma in adults.

The FDA announces it did not meet the June 25 PDUFA action date on the sNDA for active psoriatic arthritis treatment, upadacitinib.

COSMOS phase 3b study data demonstrated the effectiveness of guselkumab in patients diagnosed with psoriatic arthritis.

The FDA has approved a single-dose pre-filled pen for dupilumab (Dupixent, Sanofi and Regeneron) for at-home administration.

Mallinckrodt announces the FDA approval of StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adults with thermal burns.

The B-SIMPLE4 phase 3 trial achieved positive efficacy results for the treatment of molluscum contagiosum.

John Browning, MD, FAAD, FAAP, MBA, discusses the impact of the recent FDA approval of secukinumab (Cosentyx, Novartis) for the treatment of moderate to severe plaque psoriasis in children and adolescents.