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FDA Accepts Ortho Dermatologic’s NDA for Novel Plaque Psoriasis Treatment, IDP-118

The US Food and Drug Administration has accepted Ortho Dermatologic’s New Drug Application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion, an investigational topical treatment for plaque psoriasis. The PDUFA action date is June 18, 2018. If approved, IDP-118 will be the first and only topical lotion that contains a unique combination of …

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FDA Approves Jansen’s Golimumab for PsA, AS

Golimumab dermatology

The U.S. Food and Drug Administration (FDA) approved Jansen’s SIMPONI ARIA® (golimumab) for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Simponi is the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion.The new approvals follow the first FDA approval of SIMPONI ARIA® in 2013 …

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FDA expands indications for SculpSure

SculpSure FDA approved

The U.S. Food and Drug Administration granted an expanded FDA 510(k) clearance in September for Cynosure’s non-invasive body contouring product, SculpSure. This body contouring laser treatment is now cleared to treat the submental area. SculpSure has also been cleared to treat the abdomen, flanks, back, and inner and outer thighs. …

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FDA Clears Xstrahl Photoelectric Therapy System

fda approved Xstrahl

Xstrahl has received FDA 510K clearance for the marketing of its latest skin cancer therapy device. The Photoelectric Therapy System is a compact and ergonomic superficial X-Ray therapy system operating in the 10kV to 80kV range intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms …

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Recruitment underway for atopic dermatitis serlopitant trial

atopic dermatitis serlopitant

An investigational treatment that inhibits a receptor implicated in itch may hold promise for treatment of chronic pruritus, recent data suggest. Serlopitant, an oral neurokinin 1 (NK-1) receptor antagonist, has been evaluated in two trials that met their primary endpoints, according to investigators. Now, recruitment is underway for a randomized, …

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Sonoma Pharmaceuticals Launches Loyon

Sonoma Pharmaceuticals Launches Loyon

Sonoma Pharmaceuticals, Inc. has begun US commercialization of the company’s new Loyon® product. Under the supervision of a healthcare practitioner, Loyon is intended to manage and relieve the scaling, erythema, and itching associated with various types of dermatoses including seborrhea and seborrheic dermatitis. Loyon is a unique, patented combination of …

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