Drugs

Data Reinforce Nirsevimab RSV Efficacy: Sanofi/AstraZeneca

Sanofi and AstraZeneca say a pre-specified pooled analysis of Phase 3 and Phase 2b data demonstrates efficacy of 79.5% for their nirsevimab against medically attended lower respiratory tract infections, including hospitalizations, caused by the respiratory syncytial virus (RSV). A Sanofi media statement says the safety profile across the nirsevimab and placebo groups as reported in previous trials remains similar.

“These findings contribute to the growing body of evidence suggesting that nirsevimab can protect all infants through their first RSV season with a single dose,” the statement says.

Nirsevimab is described as an investigational long-acting antibody designed to protect all infants from birth entering their first RSV season with a single dose. FDA has granted it breakthrough therapy designation.

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