Drugs

FDA OKs Arcutis’ Zoryve for Pediatric Eczema

FDA has approved an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children ages 2 to 5, expanding access to the company’s once-daily, steroid-free topical therapy. “In clinical trials, Zoryve cream 0.05% rapidly improved eczema severity, with about 40% of children achieving a 75% improvement and over one-third reporting meaningful itch reduction after just four weeks,” the company says.

Zoryve cream is described as a steroid-free, once-daily formulation designed for long-term, continuous use without compromising the skin barrier. In clinical trials, the treatment was well tolerated, with no new safety concerns identified, the company says.

Atopic dermatitis (eczema) affects about 1.8 million children aged in the U.S. who require topical treatment, Arcutis says. The chronic condition causes intense itching, inflammation, and skin irritation, often disrupting sleep and quality of life for both children and families.

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