Latest News - FDA Approval/Clearance

Friday, December 15, 2017 | FDA Approval/Clearance, Product Launches and Updates

SK Breakthrough: FDA Approves Eskata (hydrogen peroxide) Topical Solution from Aclaris

The FDA has approved ESKATA™ (hydrogen peroxide) topical solution, 40% (w/w) from Aclaris Therapeutics, Inc. for the treatment of seborrheic keratoses (SKs). SKs are non-cancerous skin growths t…

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Thursday, December 14, 2017 | FDA Approval/Clearance, Product Launches and Updates

gel-e Receives US FDA Clearance to Expand its Bandage Product Line for Rx, OTC Use

The U.S. Food and Drug Administration (FDA) has cleared gel-e Inc.’s adhesive bandage for prescription (Rx) and over-the-counter (OTC) use. This 510(k) clearance expands the Co…

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Tuesday, December 12, 2017 | FDA Approval/Clearance, Allergan

Allergan's CoolSculpting Treatment Now FDA Approved to Improve Appearance Of Lax Tissue in Double Chin

The FDA has approved Allergan plc's CoolSculpting treatment for improved appearance of lax tissue in conjunction with submental fat, or double chin, treatments.  CoolSculpting for the double …

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Monday, December 04, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Merz

FDA Grants Extended Clearance of the Describe Patch for Tattoo Removal

Merz North America’s DESCRIBE® PFD Patch is now cleared by the Food and Drug Administration (FDA) for all commonly used lasers for tattoo removal. The new FDA clearance also extends …

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Thursday, November 02, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Valeant NJ

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 treatme…

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Monday, October 23, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates

FDA Approves Janssen’s Golimumab for PsA, AS

  The FDA approved Janssen’s SIMPONI ARIA (golimumab) for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Simponi is the only…

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Tuesday, October 17, 2017 | FDA Approval/Clearance, PracticalDermatology.com

FDA Clears Xstrahl Photoelectric Therapy System

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 operati…

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Friday, October 13, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates

FDA Approves Stelara for Treatment of Adolescents with Moderate To Severe Plaque Psoriasis

The FDA approved an expanded indication for Janssen Biotech, Inc.'s Stelara (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who a…

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Thursday, October 12, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Galderma

FDA Approves Injection of Restylane Silk via Cannula for Lip Augmentation

The FDA has approved the use of a small blunt tip cannula with Galderma's Restylane Silk for lip augmentation. Restylane Silk was the first FDA-approved hyaluronic acid (HA) dermal filler specific…

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Wednesday, October 04, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Solta, Valeant NJ

Meet Thermage’s New FLX System

The US Food and Drug Administration granted 510(K) clearance to Solta Medical’s new Thermage FLXTM System for smoothing skin on the face, eyes, and body. The Thermage FLX features a…

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Tuesday, October 03, 2017 | FDA Approval/Clearance, Allergan

FDA Adds Third Approved Indication for Botox Cosmetic: Forehead Lines

Allergan plc's Botox Cosmetic received ts third FDA indication -- the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adul…

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Wednesday, September 27, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Cynosure

Sculpsure Cleared to Treat Double Chins

Cynosure's SculpSure®  is now cleared for submental fat reduction. The U.S. Food and Drug Administration (FDA) granted an expanded FDA 510(k) clearance for this area, Hologic, Inc. rep…

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Wednesday, September 27, 2017 | FDA Approval/Clearance, PracticalDermatology.com

FDA Clears Fotona's StarWalker MaQX Ultra Performance Q-Switched System

The FDA has cleared Fotona's StarWalker MaQX Q-Switched laser system for treating tattoos, pigmented and vascular lesions, acne and scar revision, and permanent hair reduction. The Verde 532 mode …

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Tuesday, September 12, 2017 | FDA Approval/Clearance, PracticalDermatology.com

FDA Approves T.R.U.E. Test Ready-To-Use Patch Test for Pediatric Use

The FDA has approved SmartPractice's T.R.U.E. TEST (truetest.com) ready-to-use patch test panels for pediatric patients as young as 6 years of age. T.R.U.E. TEST is the only FDA-approved product f…

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Thursday, August 31, 2017 | FDA Approval/Clearance, Healthcare Trends, Phase 3/4 Trials, PracticalDermatology.com, PracticalDermatology.com, Product Launches and Updates, Research and Publications

GBI Research: Global Dermatology Pipeline Will See Shift Toward Increased Use of Biologics

The global dermatology pipeline, which currently comprises 850 products with a disclosed stage of development, is primarily made up of drugs at an early stage of development, with the late stages of t…

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