Drugs

FDA Delays Iterum Antibiotic NDA Review

FDA has told Iterum Therapeutics that it needs more time to review company-submitted “materials” related to the ongoing NDA review for (XXX DELETE sulopenem etzadroxil/probenecid for treating uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen. A previously scheduled 6/2 Antimicrobial Drugs Advisory Committee meeting has also been postponed, according to the company.

In January, the agency accepted the NDA for a priority review and set a 7/25 review action date. The submission is based on data from the SURE-1, SURE-2 and SURE-3 Phase 3 clinical trials, which demonstrated statistical superiority to ciprofloxacin for the primary efficacy endpoint of “clinical and microbiologic response at the test-of-cure visit for patients with a quinolone non-susceptible pathogen,” Iterum 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