LEO Pharma has closed its acquisition of dersimelagon from Tanabe Pharma after the FDA accepted the drug's NDA for filing and granted Priority Review, with a PDUFA date expected by the end of February 2027.
|Articles|October 18, 2017
FDA expands indications for SculpSure
The U.S. Food and Drug Administration granted an expanded FDA 510(k) clearance in September for Cynosure’s non-invasive body contouring product, SculpSure.
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The U.S. Food and Drug Administration granted an expanded FDA 510(k) clearance in September for Cynosure’s non-invasive body contouring product, SculpSure. This body contouring laser treatment is now cleared to treat the submental area. SculpSure has also been cleared to treat the abdomen, flanks, back, and inner and outer thighs. This treatment uses a laser to raise the temperature of body fat to disrupt and destroy fat cells, which are then naturally and permanently eliminated.
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