Latest News - FDA Approval/Clearance

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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Tuesday, August 29, 2017 | Corporate Lawsuits, FDA Approval/Clearance, PracticalDermatology.com, AbbVie, Boehringer Ingelheim, Psoriasis

FDA Greenlights Humira Biosim Cyltezo for Multiple Inflammatory Diseases

The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo™, a biosimilar to Humira®, in a pre-filled syringe for the treatment of multip…

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Friday, August 04, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Pfizer

FDA Advisory Arm Backs XELJANZ for PsA

The United States Food and Drug Administration’s (FDA) Arthritis Advisory Committee recommends the approval of Pfizer's XELJANZ® (tofacitinib) for the treatment of adults with active pso…

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Monday, July 24, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Bristol-Myers Squibb

FDA Expands Approval of Yervoy to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma

The FDA has expanded the indication for Bristol-Myers Squibb's Yervoy (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatr…

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Thursday, July 13, 2017 | FDA Approval/Clearance, PracticalDermatology.com

FDA Approves Janssen's Tremfya for Moderate To Severe Plaque Psoriasis

The FDA has approved Janssen's Tremfya (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya is the fir…

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Thursday, July 13, 2017 | FDA Approval/Clearance, PracticalDermatology.com, PracticalDermatology.com

FDA Clears Philips BlueControl Wearable Light Therapy Device to Treat Mild Psoriasis At Home

The FDA has granted Royal Philips 510(k) clearance to market the Philips BlueControl wearable light therapy device to treat mild psoriasis. In the US, BlueControl is a Class II prescription medical de…

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Thursday, June 29, 2017 | FDA Approval/Clearance, PracticalDermatology.com

FDA Approves SciBase's Nevisense for Melanoma Detection

The FDA has approved the Scibase Pre-Market Approval (PMA) for Nevisense, a device for the early detection of malignant melanoma. According to the letter from the FDA the device is intended for use on…

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