Latest News - FDA Approval/Clearance

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 …

Read the full story

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…

Read the full story

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…

Read the full story

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…

Read the full story

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…

Read the full story

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…

Read the full story

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…

Read the full story

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…

Read the full story

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…

Read the full story

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 …

Read the full story

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…

Read the full story

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, …

Read the full story

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 …

Read the full story

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…

Read the full story

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, …

Read the full story
Load More