Aesthetic Medicine

FDA Accepts Resubmitted BLA for Injection to Improve Frown Lines

By August 30, 2018

The Company is seeking approval for the treatment to temporarily improve the appearance of moderate to severe glabellar lines.

Restylane Lyft Approved to Correct Volume Deficit in the Dorsal Hand

By May 23, 2018

The approval was based on a multicenter, randomized, evaluator-blinded, split-hand study (N=89) which showed that treatment with Restylane Lyft resulted in a clinically meaningful improvement in the correction of volume deficits of treated hands for up to 6 months.

New Warnings Added to the Labeling for Kybella

By January 19, 2018

Cases of ulceration and necrosis have been reported with the administration of Kybella following injections that are too superficial.

Injectable Fillers: Adverse Events and Associated Litigation Investigated

December 26, 2017

More serious adverse events include vascular compromise resulting in necrosis, blindness

FDA: Serious Injuries With Injectable Silicone Used for Body Contouring

By November 14, 2017

Silicone injections for body contouring are often performed by unlicensed and non-medical practitioners in non-clinical settings such as residential homes or hotels.

Botox Approved for Improving Moderate to Severe Forehead Lines

By October 11, 2017

Botox Cosmetic is already approved for the temporary improvement of crow's feet lines and frown lines between the eyebrows in adults.

FDA Expands Dysport Use for Lower Limb Spasticity in Adults

By June 16, 2017

The FDA approval was based on data from a Phase 3, multi-center, prospective, double-blind, randomized, placebo-controlled study in 381 adults treated with Dysport 1000 Units, Dysport 1500 Units or placebo after a stroke or traumatic brain injury.

Juvederm Vollure XC Approved for Facial Wrinkles and Folds

By March 20, 2017

The injectable gel is balanced with firmness and low cohesivity delivering results that last up to 18 months from the initial or touch-up injection.

Two Dermal Fillers Approved for Treating 'Laugh Lines'

By December 29, 2016

Galderma announced that the Food and Drug Administration (FDA) approved 2 new dermal fillers for the treatment of nasolabial folds (NLF), also known as "laugh lines," in patients aged >21 years old.