Galderma Receives FDA Approval for Restylane® Defyne for Chin Augmentation
Galderma announces that the U.S. Food and Drug Administration (FDA) has...
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Tag: FDA
FDA approves Libtayo® (cemiplimab-rwlc) as first and only treatment for advanced cutaneous squamous cell carcinoma
The U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates...
Read MoreStatement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions
When I announced the Drug Competition Action Plan, or DCAP, in June 2017, I committed the FDA to a number of new steps to increase competition in the market for prescription...
Read MoreAVITA Medical Announces FDA Approval of the RECELL® System for the Treatment of Severe Burns in the U.S.
AVITA Medical, a global regenerative medicine company, announced that the U.S. Food and Drug Administration (FDA) approved the Company’s Premarket Approval (PMA) application to market the RECELL® Autologous Cell Harvesting...
Read MoreStatement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”
Our most fundamental obligation to the American public is providing patients with access to safe and effective medical products to meet their health care needs as well as protecting them...
Read MoreFDA approves new treatment for a rare genetic disorder, Fabry disease
The U.S. Food and Drug Administration approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults with Fabry disease who...
Read MoreCynosure Receives FDA 510(k) Clearance for SculpSure™, the World’s First Hyperthermic Laser Treatment for Non-Invasive Fat Reduction
Cynosure, Inc. a leader in laser- and light-based aesthetic treatments, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SculpSure™, the...
Read MoreGalderma receives FDA approval of novel treatment option for rosacea patients
Soolantra® (ivermectin) Cream, 1% found to be well tolerated with powerful results seen as early as two weeks
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Sep/Oct Issue
