Drugs

FDA Lifts Clinical Hold on Huntington’s Therapy

FDA has lifted a clinical hold against Voyager Therapeutics and its planned clinical trial for VY-HTT01 for treating Huntington’s disease. The hold removal followed a comprehensive review of the company’s chemistry, manufacturing and controls information previously submitted to the agency, according to the Voyager. The company plans to initiate VYTAL, a Phase 1/2 clinical trial of VY-HTT01, later this year.

Huntington’s disease is a neurodegenerative disorder caused by mutations in the huntingtin (HTT) gene, which causes the production of an abnormally large amount of HTT protein that accumulates inside nerve cells and causes their death. VY-HTT01 is described as a type of gene silencing therapy aimed at addressing the underlying cause of the disease by significantly reducing the amount of damaging HTT protein produced.

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