Biologics

FDA Backs Monovalent XBB.1.5 Covid Vaccine

One day after an FDA advisory committee voted 21 to 0 (see story) to recommend that the Covid-19 vaccination program for the 2023-2024 season should contain a monovalent vaccine comprising the XBB-lineage variant, the agency posted a notice that adhered to the panel recommendation.

The 6/16 FDA notice advised manufacturers that they should develop vaccines with a monovalent XBB.1.5 composition. “This recommendation incorporates advisory committee input and is based on the totality of the available evidence to select the vaccine composition that the FDA anticipates will best protect public health,” it says. “The agency anticipates the timely submission of the data and filings to support FDA action on updated Covid-19 vaccines in order to make vaccines available this fall that meet our standards for safety, effectiveness and quality.”

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