Drugs

FDA OKs Zoryve Cream Expanded Use

FDA has approved an Arcutis Biotherapeutics supplemental NDA to expand the indication for Zoryve (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, in children aged six to 11 years. Previously, Zoryve was approved for the same indication in people aged 12 years and older.

Approval of the expanded patient population is based on data from a four-week maximal usage systemic exposure (MUSE) study in children aged six to 11 years with plaque psoriasis. “Pharmacokinetic, safety, tolerability, and efficacy data from this study were generally consistent with data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 trials in adults,” the company says. “Results from a second MUSE study, in children ages two to five years, as well as data from an ongoing open label extension study to assess the long-term safety of roflumilast cream 0.3% in individuals with plaque psoriasis two years of age and older (ARQ-151-306), will be the subject of a future FDA review.”

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