Latest News - FDA Approval/Clearance

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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Monday, March 20, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Allergan

FDA Approved Juvéderm Vollure XC for Correction of Facial Wrinkles and Folds

The FDA has approved Allergan plc's Juvéderm Vollure XC for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21. In the US piv…

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Thursday, March 02, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, American Academy of Dermatology, BTL

BTL Aesthetics To Unveil New Ultra Femme 360° Technology for Vaginal Rejuvenation at AAD

BTL Industries is introducing its new 360° technology to leading cosmetic dermatologists and physicians during the annual American Academy of Dermatology (AAD) Conference taking place in Orlando, …

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Thursday, February 16, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Valeant NJ

FDA Approves Valeant's SILIQ For Moderate-To-Severe Plaque Psoriasis

The FDA has approved the Biologics License Application (BLA) for Valeant Pharmaceutical's SILIQ (brodalumab) injection, for subcutaneous use, a monoclonal antibody that targets the IL-17 receptor …

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Thursday, January 19, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Allergan

FDA Approves RHOFADE™ (Oxymetazoline Hydrochloride) Cream, 1% For Persistent Facial Erythema Associated With Rosacea

The FDA has approved Allergan's RHOFADE™ cream for the topical treatment of persistent facial erythema associated with rosacea in adults. Approval was based on two clinical studies that eval…

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Wednesday, December 14, 2016 | FDA Approval/Clearance, PracticalDermatology.com, Anacor, Pfizer

FDA Approved Eucrisa (Crisaborole) for AD

The U.S. Food and Drug Administration approved Eucrisa (crisaborole) ointment to treat mild-to-moderate eczema in patients two years of age and older.  Eucrisa, applied topically twice daily, …

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Tuesday, December 13, 2016 | FDA Approval/Clearance, PracticalDermatology.com

AnaptysBio, Inc.’s IL-33-Blocker Cleared for Phase 2a Trials in AD, Peanut Allergy

The United Kingdom Medicines and Healthcare Products Regulatory Agency has green lighted a Phase 2a clinical trial for AnaptysBio, Inc.’s ANB020 for the treatment of adults with moderate-to-seve…

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Monday, December 12, 2016 | FDA Approval/Clearance, PracticalDermatology.com, Galderma

Galderma's Restylane Refyne and Restylane Defyne Fillers FDA Approved for “Laugh Lines”

The FDA  approved two new products for the treatment of nasolabial folds (NLF) or “laugh lines,” in patients over the age of 21 -- Galderma's Restylane Refyne and Restylane Defyne…

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Monday, November 21, 2016 | Acquisitions and Mergers, FDA Approval/Clearance, Personnel/Company News, PracticalDermatology.com, Product Launches and Updates, Merz, Ulthera

Merz On The Move: Reflections On Fiscal Year 2015/16

Merz Pharma’s core business has grown by 8.9 percent from EUR 809.8 million to EUR 881.9 million in fiscal 2015/16, the company reports. The company’s total revenue of EUR 1,092.9 milli…

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Tuesday, November 08, 2016 | FDA Approval/Clearance, PracticalDermatology.com, Syneron

FDA Clears Syneron Candela's Profound SubQ to Improve Cellulite

Syneron Candela  received FDA 510(k) clearance for Profound when using the SubQ handpiece and cartridge to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III, as su…

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Monday, November 07, 2016 | FDA Approval/Clearance, PracticalDermatology.com, PracticalDermatology.com, Product Launches and Updates, Amgen

FDA Approves Expanded Use Of Enbrel To Treat Children With Chronic Moderate-To-Severe Plaque Psoriasis

The FDA has approved the supplemental Biologics License Application (sBLA) for the expanded use of Amgen's Enbrel (etanercept), making it the first and only systemic therapy to treat pediatric pat…

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Wednesday, October 19, 2016 | FDA Approval/Clearance, Personnel/Company News, PracticalDermatology.com, Product Launches and Updates

Biofrontera Launches Ameluz for Actinic Keratosis

Biofrontera AG initiated the US commercial launch of its combination topical prescription drug Ameluz and medical device BF-RhodoLED, which has been FDA approved to treat mild to moderate actinic kera…

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