Biologics

FDA Revises Covid Vaccine Composition Recommendation

FDA is updating its advice on this fall’s Covid-19 vaccine composition based on a recent review of circulating Covid cases in the U.S. “Based on the most current available data, along with the recent rise in cases of Covid-19 in areas of the country, the agency has further determined that the preferred JN.1-lineage for the Covid-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible,” an FDA notice says.

Earlier this month, an FDA advisory committee unanimously voted to recommend a monovalent JN.1-lineage vaccine composition. “Following the vote, the committee discussed considerations for the selection of a specific JN.1 lineage SARS-CoV-2 strain (e.g., JN.1 or KP.2) and expressed a strong preference for JN.1,” the notice says. Based on newer data, the latest change is intended to ensure that the Covid-19 vaccines (2024-2025 Formula) more closely match circulating SARS-CoV-2 strains, it says.

FDA says it does not expect that a change to KP.2 will delay the availability of the vaccines in the U.S.

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