Biologics

Kennedy Ally Says Makary Blocking Covid Shot Withdrawal

Robert Malone, the vice chair of the CDC Advisory Committee on Immunization Practices (ACIP) and a close ally of HHS secretary Robert F. Kennedy Jr., has publicly accused FDA commissioner Marty Makary of blocking the effort to remove mRNA Covid vaccines from the market. Axios reports that when Malone responded to a post on X that said FDA needed to take the Covid vaccines off the market, he said, “We are aligned.” Asked who and what was the hold-up, he posted, “Commissioner FDA.”

“I’m not deaf to the calls that we need to get the Covid vaccine mRNA products off the market,” Malone reportedly said during a call with MAHA Action, a nonprofit aligned with Kennedy’s ideas. “All I can say is stay tuned and wait for the upcoming ACIP meeting. If FDA won’t act, there are other entities that will.”

Axios says it expects the vaccines to be on the February ACIP meeting agenda and notes that the ACIP member leading a task force reviewing the safety of the Pfizer and Moderna jabs has previously described them as “the most failing medical products in the history of medical products,” and called for them to be removed from the market, as reported by the New York Times.

Kennedy has publicly criticized the Covid shots but also has said he wouldn’t restrict access for those who want them.

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