Latest News - FDA Approval/Clearance

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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Monday, June 26, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Research and Publications

Study Tallies Adverse Events Reported to FDA for Cosmetics

There were 5,144 adverse events reported to the US Food and Drug Administration (FDA) for cosmetics and personal care products from 2004 to 2016, an average of 396 events per year, according to a new …

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Friday, June 23, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Tattoo

Wontech’s Pico Laser Gets FDA Nod

The U.S. Food and Drug Administration (FDA) cleared WONTECH’s picosecond laser device for tattoo removal. PICOCARE removes tattoos in various colors in less time with 1064nm, 532nm, 595nm, an…

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Tuesday, June 20, 2017 | FDA Approval/Clearance

FDA Approves New Antibiotic for Skin Infections

The FDA has approved Melinta Therapeutics' Baxdela (delafloxacin) for adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Baxdel…

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Thursday, June 15, 2017 | FDA Approval/Clearance

FDA Cracks Down on Sonar For Distributing Unapproved Derm Drugs

U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharm…

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Thursday, June 15, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Cynosure

Cynosure's SculpSure Cleared for Back, Inner and Outer Thighs

The U.S. Food and Drug Administration (FDA) granted an expanded clearance for Cynosure's SculpSure to treat the back and inner and outer thighs. The SculpSure treatment is already FDA-clea…

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Tuesday, June 13, 2017 | FDA Approval/Clearance

FDA Warns Public About Black Henna Tattoo Risks

Black henna temporary tattoos can cause serious skin reactions, the US Food and Drug Administration (FDA) warns. For centuries, traditional henna, a reddish-brown plant extract, has been used to dy…

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Tuesday, May 09, 2017 | FDA Approval/Clearance

FDA Accepts Aclaris Therapeutics’ NDA for Topical Treatment of Seborrheic Keratosis

The FDA has accepted Aclaris Therapeutics' New Drug Application (NDA) for A-101 40% topical solution, an investigational drug for the potential treatment of seborrheic keratosis (SK). The NDA acce…

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Thursday, March 30, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, AbbVie

FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to Humira Prescribing Information

The FDA approved the inclusion of moderate to severe fingernail psoriasis data in AbbVie's Humira (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis…

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Tuesday, March 28, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Regeneron, Sanofi

FDA Approves New Eczema Drug Dupixent

The FDA has approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Regeneron Pharmaceuticals, Inc.'s Dupixent is intended for patients whose ec…

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Friday, March 24, 2017 | FDA Approval/Clearance, PracticalDermatology.com

FDA Approves First Treatment for Rare Form of Skin Cancer

The FDA granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have …

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