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...
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...
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...
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...
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....
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...
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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March/April Issue
