FDA Policy/General

Allergan Skin Smoother Approved by FDA

FDA has approved Allergan Aesthetics’ Skinvive by Juvéderm and its use to improve skin smoothness of the cheeks in adults over the age of 21. The company says it is the first hyaluronic acid intradermal microdroplet injection for skin smoothness available in the U.S. with results lasting through six months.

Skinvive’s approval was based on data from a randomized, multicenter, evaluator-blinded, controlled pivotal study that Allergan says showed the majority of patients saw a one point or greater improvement on the Allergan Cheek Smoothness Scale at one month and six months. “In a patient reported satisfaction with skin questionnaire, 63% (78/124) of patients were satisfied with how radiant their facial skin looked at six months compared with 11% before treatment,” it says. At six months, 72% were satisfied with how hydrated their facial skin looked at six months compared to 24% before treatment.”

Allergan says the majority of clinical study subjects reported experiencing side effects such as redness, lumps/bumps, swelling, bruising, tenderness, pain, firmness, discoloration, and itching at the injection site.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome