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Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.
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The European Medicines Agency regulatory committee joins the FDA in saying there's no known tie between the semaglutide obesity drugs and suicide.
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The study found that between 2013 and 2017, there were 46 cancer drugs granted accelerated approval. Of those, only 43% improved or extended lives in confirmatory trials.
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The drug's failure is a disappointment for patients and advocates, who pressed the FDA and other federal agencies to fund and approve more experimental therapies for the fatal muscle-wasting disease.
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The FDA granted a request for a qualified health claim from Danone North America. Such claims lack full scientific support but are allowed as long as they include disclaimers.
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The EPA is tightening regulation of ethylene oxide, a carcinogenic gas used to sterilize medical devices. The agency is trying to balance the interests of the health care industry supply chain with those of communities where the gas creates airborne health risks.
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Lawmakers and regulators are trying to understand how AI is changing health care and how it should be regulated. The industry fears overreach.
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It's our monthly medical roundtable, when we dive into the month's most significant health headlines.
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HHS issued a summary about a Jan. 12 discussion between Secretary of Health Xavier Becerra and Canadian Health Minister Mark Holland.
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Surgeon General Dr. Joseph Ladapo has expressed concerns about the mRNA vaccine. Two Florida experts are confused by his questions, saying they don't make much sense.