Drugs

Scynexis Clinical Hold Lifted on Antifungal

FDA has lifted a clinical hold against Scynexis’s ibrexafungerp that will allow it to proceed with its Phase 3 MARIO study evaluating its use as a non-azole, oral step-down for patients with invasive candidiasis and candidemia. The company says ibrexafungerp, if approved, could give healthcare providers the opportunity to step-down their patients to a non-azole oral therapy that retains the glucan synthase inhibition of the intravenous-only echinocandins, which are the gold standard for treating Candida infections, potentially allowing for faster discharge from the hospital.

Ibrexafungerp is being developed under a licensing agreement with GSK. The first-in-class antifungal is currently approved for treating vulvovaginal candidiasis (VVC) and for reducing the incidence of recurrent VVC.

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