Drugs

Parabilis’ FOG-001 Wins FDA Fast Track for Desmoid Tumors

FDA has granted Parabilis Medicines a fast track designation for FOG-001, a first-in-class inhibitor targeting the β-catenin:TCF interaction, for treating desmoid tumors. The action is based on the company’s early clinical data showing signs of meaningful antitumor activity.

In an ongoing Phase 1-2 study, 12 desmoid tumor patients had received FOG-001 as of the August cutoff, and tumor shrinkage was observed in all evaluable, according to the company. It says the therapy contributed to an 80% objective response rate among those with more than one post-baseline scan. Responses appeared independent of tumor location, prior gamma-secretase inhibitor exposure, or specific APC/CTNNB1 mutations. Parabilis also says there were no reported Grade 4/5 treatment-related events, discontinuations, or high-grade GI or skin toxicities.

Parabilis is also exploring FOG-001 across a range of other Wnt/β-catenin–driven tumors, including adamantinomatous craniopharyngioma, ameloblastoma, salivary gland cancers, and solid pseudopapillary neoplasm, with combination-therapy investigations planned for more complex cancers such as microsatellite-stable colorectal cancer. More data are expected in 2026, it adds.

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