Lady Parts: Bruce E. Katz, MD, Ushers in Cosmetic Surgery’s Final Frontier
In the November PSP cover story, Bruce E. Katz, MD, talks about how he's helping to usher in cosmetic surgery's final frontier--vaginal rejuvenation.
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FDA Expands Sunscreen Options With First New Active Ingredient in Decades
The agency has added bemotrizinol to the over-the-counter sunscreen monograph, making it the first new sunscreen active ingredient approved for use in the United States since the late 1990s.
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Sciton Launches Super MOXI Laser Featuring Twin-Beam Delivery to Halve Treatment Times
Operating with a 16W diode, the platform expands full-body skin revitalization settings across mJOULE and JOULE X systems.
Evolus Advances Mid-Face Filler Toward FDA Approval
Evolus has submitted the final module of its PMA application to the FDA for Evolysse Sculpt, an injectable HA gel for mid-face volume restoration.
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FDA Approves Treatment for Moderate-to-Severe Chronic Hand Eczema
Regulatory approval is based on clinical trials showing improvements in symptom severity and treatment success at 16 weeks.
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FDA Extends Review of Opzelura for Pediatric Atopic Dermatitis
Incyte’s sNDA for ruxolitinib cream in children ages 2–11 now faces a new action date to allow additional data review.
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Skinvive by Juvéderm Targets Neck Lines in New FDA Filing
If approved, Skinvive by Juvéderm will be the first hyaluronic acid injectable treatment option aiming to reduce neck lines.
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FDA Approves Two New Hyaluronic Acid Fillers
One newly approved HA filler showed statistical superiority to Restylane-L at all measured time points over 12 months, while the other was superior at six and nine months despite 20% more Restylane-L being used.
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Vivace Ultra Receives FDA Clearance
Aesthetics Biomedical’s Vivace Ultra microneedling RF device was cleared by the FDA for use in dermatological and surgical procedures.
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UCLA Researchers Work On Lab Test to Detect Implant Ruptures
The UCLA researcher’s lab test would use blood and urine samples to provide a simpler and effective method for detecting implant ruptures.
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FDA Approves Revance Daxxify for Frown Lines
Revance Therapeutics received FDA approval for Daxxify to be used as an injectable to improve moderate to severe frown lines in adults.
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FDA Accepts Revance Resubmission for Frown Line Treatment
The FDA has accepted Revance’s BLA resubmission for DaxibotulinumtoxinA for Injection, designed to treat severe glabellar lines.
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Allergan Celebrates 20 Years of Botox
Allergan Aesthetics is celebrating Botox’s 20th anniversary as an FDA-approved product with a cross-country art installation.
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Renuvion Maker Notified of Pending FDA Medical Device Safety Communication
Apyx Medical Corp.—developer of Helium Plasma Technology, which is marketed and sold as Renuvion® in the cosmetic surgery market —has been notified by the U.S. FDA that the agency intends to post a Medical Device Safety Communication related to the Apyx Medical’s Advanced Energy products.
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Revance Resubmits BLA to FDA for DaxibotulinumtoxinA for Injection
Revance Therapeutics Inc, a biotechnology company focused on innovative aesthetic and therapeutic...
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FDA Urges Companies to be ‘Recall Ready’
The U.S. FDA’s final guidance describes the steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled product is on the market.
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FDA Advisory Panel Red Lights Integra’s Breast Reconstruction Mesh
An advisory panel on general and plastic surgery voted against recommending FDA approval of Integra LifeSciences’ SurgiMend mesh for the specific indication of breast reconstruction, even though the device has been used in breast reconstruction for more than a decade under a 510(k) clearance, MD+DI reports.
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FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants
The U.S. Food and Drug Administration took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions, according to a news release.
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