Drugs

Greenwich Gets Fast Track for Breast Cancer Therapy

FDA has granted Greenwich LifeSciences fast track status for GLSI-100, an investigational immunotherapy aimed at preventing breast cancer recurrences. The designation applies to HLA-A*02-genotype patients with HER2-positive breast cancer who have completed standard HER2-targeted therapy.

The company says GLSI-100 has already shown promise in earlier studies. In a Phase 2b trial involving HER2-positive breast cancer patients, the treatment reduced metastatic recurrences by 80% or more over five years compared with placebo. The therapy was well tolerated, with no serious adverse events reported, it says.

The ongoing Phase 3 FLAMINGO-01 study, led by Baylor College of Medicine, is enrolling up to 750 patients globally to further evaluate GLSI-100’s safety and efficacy, according to the company.

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