Biologics

Panel Recommends Dominant Covid Variant for Upcoming Vaccines

FDA’s Vaccines and Related Biological Products Advisory Committee has voted 8 to 0 to recommend updating Covid-19 vaccines for the 2026-2027 immunization season to target the currently dominant XFG variant, a descendant of the JN.1 lineage that now accounts for the majority of U.S. Covid cases.

An FDA briefing document released ahead of the meeting noted that the previously dominant LP.8.1 strain has been overtaken by newer JN.1-lineage variants, including XFG and NB.1.8.1.

Several panel members voiced concern about limited real-time surveillance data and reduced federal monitoring efforts. They said updated epidemiological and immunogenicity data were lacking and called for more frequent advisory committee meetings to respond to the virus’s continued evolution.

The recommendation aligns with recent guidance from the World Health Organization, which advised vaccine manufacturers to consider LP.8.1 or more recently circulating variants such as XFG.

Manufacturers including Moderna, Pfizer and Novavax have indicated they are prepared to produce updated vaccines targeting the XFG strain ahead of the fall vaccination campaign.

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