Drugs

Clinical Hold Removed on Dravet Syndrome Drug

FDA has removed a partial clinical hold on Stoke Therapeutics’ zorevunersen (STK-001) and its use in children and adolescents with Dravet syndrome. The therapy was under a modified partial hold since 3/2023 that allowed the administration of a single dose of STK-001 (70 mg) in its ongoing Phase 1-2 MONARCH study. Now that the hold is removed, the company says it will advance zorevunersen’s clinical program into a Phase 3 registrational study by year-end.

STK-001 is described as a proprietary antisense oligonucleotide, and the first potential new medicine to address the genetic cause of Dravet syndrome, which is a genetic form of epilepsy characterized by frequent, prolonged and refractory seizures that begin during the first year of life. Current anti-seizure medicines do not adequately control the seizures, the company says.

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