Latest News - FDA Approval/Clearance

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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Tuesday, October 18, 2016 | FDA Approval/Clearance, PracticalDermatology.com, Merz

FDA Clears Merz Aesthetics' Cellfina System for Long-Term Improvement of Cellulite

The FDA has cleared the Cellfina System from Merz Aesthetics, a division of Merz North America, for the long-term improvement in the appearance of cellulite on the buttocks and thighs of adult females…

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Tuesday, October 18, 2016 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, National Psoriasis Foundation, Pfizer

Biosim Update: Pfizer to Begin Shipping INFLECTRA in Late November 2016

Pfizer Inc. will begin shipment of INFLECTRA (infliximab-dyyb) for injection, a biosimilar of REMICADE1 (infliximab) to wholesalers in the United States in late November 2016. INFLECTRA will be the…

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Thursday, October 13, 2016 | FDA Approval/Clearance, PracticalDermatology.com, Allergan

Sweden Greenlights Allergan’s Double Chin-Melting BELKYRA®

The Swedish Medical Products Agency has greenlighted Allergan’s BELKYRA® (deoxycholic acid) for submental fat reduction. BELKYRA® is already licensed in Canada, Australia, Iceland, Hu…

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Monday, September 26, 2016 | FDA Approval/Clearance, PracticalDermatology.com

Stelara Adds New Approval: Crohn's Disease

The FDA has approved STELARA® (ustekinumab) from Janssen Biotech, Inc., for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or we…

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Monday, September 26, 2016 | FDA Approval/Clearance, PracticalDermatology.com, Regeneron, Sanofi

Regeneron and Sanofi's Dupilumab Biologics License Application Accepted for Priority Review by FDA

The FDA has accepted for priority review the Biologics License Application (BLA) for dupilumab from Regeneron Pharmaceuticals, Inc. and Sanofi for the treatment of adult patients with inadequately con…

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Friday, September 23, 2016 | FDA Approval/Clearance, PracticalDermatology.com, Amgen, Psoriasis

FDA Approves Humira Biosimilar

The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Amjevita is approved for the following ind…

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