Drugs

FDA Has ‘No Plans’ to Pull Abortion Pill: Makary

Speaking at the Semafor World Economy Summit, FDA commissioner Martin Makary said the agency has “no plans to take action” to restrict the availability of mifepristone, the pill used in most U.S. medication abortions. He hedged his statement a bit, saying that an ongoing set of data on the drug is coming into the agency and, “If the data suggest something or tells us that there’s a real signal, we can’t promise we’re not going to act on that data.”

Addressing another issue facing the agency, Makary said he believes that many Americans would welcome a move by HHS secretary Robert F Kennedy, Jr., to pull the government’s recommendation that children receive the Covid-19 vaccine.

“Most Americans do not believe in the Covid booster shot for young healthy children at this point,” he said. “If he does something with the Covid vaccine in children, I think it’ll be warmly welcomed by many Americans.”

While stating that “vaccines save lives and any death from a vaccine-preventable illness is a tragedy,” Makary disclosed that he has not had any of the Covid booster shots.

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