Drugs

Syndax Gets Priority Review for Revuforj sNDA

FDA has granted Syndax Pharmaceuticals a priority review of its supplemental NDA for Revuforj (revumenib) as a treatment for relapsed or refractory (R/R) acute myeloid leukemia (AML) with mutant NPM1 (mNPM1) — the most common genetic alteration found in adult AML patients. The agency has set a 10/25 user fee review action target date.

Revuforj is a first-in-class, oral menin inhibitor that received initial FDA approval in 2024 for patients with R/R acute leukemia harboring KMT2A rearrangements. The sNDA is based on data from the pivotal AUGMENT-101 trial, which evaluated revumenib in mNPM1 AML patients. The trial met its primary endpoint, demonstrating a 23% complete remission rate, with a 63% overall response rate, Syndax says. Notably, many patients achieving remission also showed minimal residual disease negativity, it 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