Drugs

FDA, Vanda Agree on Dispute Actions

FDA and Vanda Pharmaceuticals have agreed to a framework for resolving their ongoing disputes about the company’s sleep-wake cycle drug Hetlioz (tasimelteon) and its gastroparesis drug tradipitant. A Vanda statement lists these features of the agreement:

FDA will conduct an expedited re-review of the partial clinical hold preventing long-term clinical studies of tradipitant to treat motion sickness by 11/26 and will continue its review of the company’s NDA for this indication with the current PDUFA action date of 12/30;
FDA will conduct an expedited re-review of Vanda’s sNDA for Hetlioz to treat jet lag disorder by 1/7/2026, including the consideration of alternative or narrowed indications focusing on the sleep-related aspects of jet lag disorder;
FDA and Vanda will seek a temporary pause of the ongoing administrative proceedings before the FDA commissioner on Vanda’s NDA for tradipitant to treat gastroparesis until 1/7/2026;
FDA and Vanda have sought a pause in the company’s suit challenging FDA’s practice of taking up to 12 months, rather than the statutory 180 days, to decide NDAs;
Vanda will dismiss its suit challenging the FDA partial clinical hold preventing long-term studies of tradipitant to treat motion sickness; and
Vanda will dismiss its suit on its request to provide information to prescribers and patients about Hetlioz’ efficacy in jet lag disorder.

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