Drugs

Vanda Wins Long-Sought Hearing on Hetlioz sNDA for Jet Lag

FDA has granted Vanda Pharmaceuticals a long-sought formal evidentiary public hearing to review the agency’s proposal to refuse approval of a supplemental NDA for Hetlioz (tasimelteon) and its use for treating jet lag disorder. A 3/2 letter from FDA’s Office of the Commissioner confirmed the hearing under 21 CFR Part 12, according to the company, after which a presiding officer will issue an initial decision.

The company described the move as a rare regulatory step, noting that formal evidentiary hearings under Part 12 in the context of drug approvals have not been granted in decades. It further characterized the decision as both a procedural victory for the company and a step toward greater transparency in the agency’s review process.

The hearing follows a protracted legal dispute between Vanda and FDA over the jet lag indication. In 8/2025, the U.S. Court of Appeals for the D.C. Circuit ruled in the company's favor in its lawsuit against the agency. The court found that the FDA had failed to adequately address Vanda’s clinical evidence, including statistically significant trial results, and remanded the matter to the agency with instructions to either resolve the application or initiate a hearing (see earlier story).

Vanda first submitted its application in 2018, but the process quickly became mired in legal disputes. A federal district court previously determined that FDA had violated the Food, Drug, and Cosmetic Act by delaying resolution of Vanda’s request for a hearing. Rather than grant a hearing, FDA denied approval outright, prompting Vanda to appeal.

Hetlioz is currently approved in the U.S. for treating Non-24-Hour Sleep-Wake Disorder and for nighttime sleep disturbances associated with Smith-Magenis syndrome.

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