Drug Watch

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.

Emma Guttman-Yassky, MD, sits down with Dermatology Times® to discuss recently published results of a phase 3 study evaluating upadacitinib (Rinvoq, AbbVie) as a potential treatment of atopic dermatitis.

Revance provides an update on the approval process for its injectable daxibotulinumtoxinA (DAXI) for the treatment of glabellar lines.

Dermavant has submitted a New Drug Application (NDA) to the FDA seeking approval for its novel topical for the treatment of mild, moderate, and severe plaque psoriasis in adult patients.

The anti–PD-L1, fully human monoclonal antibody cosibelimab will be examined in a cohort of patients with metastatic cutaneous squamous cell carcinoma (cSCC) as part of an ongoing phase 1 study.

Ruxolitinib cream (Jakafi, Incyte) demonstrated positive results in 2 phase 3 studies investigating the topical for treatment of vitiligo in patients 12 years and older

Novel biologics are moving into off-label indications to expand the dermatologic armamentarium for a broad range of inflammatory skin diseases.

The FDA has granted an Orphan Drug designation to the investigational tumor-infiltrating lymphocyte therapy ITIL-168 for the treatment of patients with stage IIB to IV melanoma.

Voltaire-X study data shows that switching several times between Cyltezo and Humira results in similar pharmacokinetics, efficacy, immunogenicity, and safety in people with moderate to severe chronic plaque psoriasis.

Phase 3 trial of Otezla shows improved measures of disease severity in adults with mild to moderate plaque psoriasis regardless of their Body Surface Area affected by the disease.

Nemolizumab shows positive results according to a recently published post hoc analysis of a phase 2b trial evaluating the drug vs placebo in adult patients with moderate to severe atopic dermatitis (AD).

Single-agent pembrolizumab yielded robust antitumor activity in patients with locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma.