Biologics

FDA Plans Pfizer, Moderna Vaccine Heart Warning

FDA plans to “move rapidly” to add a Warning to fact sheets for the Pfizer and Moderna Covid-19 vaccines about the rare risk of developing inflammatory heart conditions. Politico reports that CBER vaccine division deputy director Doran Fink told a 6/23 meeting of a Centers for Disease Control (CDC) advisory committee meeting on Covid vaccines that the Warning is warranted based on the available data.

A CDC safety panel has found there is a “likely association” between the two vaccines and cases of myocarditis and pericarditis in vaccine recipients, the report says.

There reportedly are more than 1,200 cases under investigation as of 6/11 among more than 150 million people who received either of the mRNA vaccines. CDC says more cases occur after the vaccines’ second shots. More cases have been reported among Pfizer vaccine recipients, possibly because that shot is approved for patients age 12 and up, while Moderna is only for adults.

Officials reportedly are especially focused on cases in those age 30 and younger.

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