Drugs

Review Extended on Denali’s Hunter Syndrome Drug

FDA has extended by three months its review of a Denali Therapeutics BLA for tividenofusp alfa, a potential treatment for mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome. According to the company, the review action target date has been pushed back — from 1/5/2026 to 4/5 /2026 — after Denali submitted updated clinical pharmacology data in response to an FDA information request. The agency determined that the data submission was considered a major amendment.

The BLA was accepted for priority review in July. Tividenofusp alfa is described by the company as a next-generation enzyme replacement therapy designed to address both the cognitive and physical manifestations of Hunter syndrome. The rare genetic disorder is caused by a deficiency of the iduronate 2-sulfatase (IDS) enzyme, leading to the accumulation of harmful complex sugars in the body and brain, it says. The therapy uses the company’s proprietary TransportVehicle platform to deliver IDS throughout the body and into the brain.

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

Read more

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