Food and Drug Administration

Image: Shutterstock (Shutterstock)An experimental treatment for Alzheimer’s disease may pose a life-threatening risk of brain bleeding for certain patients, an investigative report out this week suggests. The paper, published Monday in the journal Science, details the case of a 65-year-old woman who died from massive hemorrhaging that could have arisen from taking a common blood thinner while on the experimental drug. The incident is believed to be the second similar death linked to the treatment, which will be reviewed…

The Food and Drug Administration is warning consumers not use certain Mighty Bliss heating pads because the devices can cause electric shocks, skin burns, rashes, or irritation. For a product that claims to treat pain, that sure is the opposite of relief, and, while we’re at it, bliss.The agency’s warning comes the same week Whele LLC, the company which distributes the Mighty Bliss heating pads, announced a national voluntarily recall of of more than 544,000 devices due to safety concerns. The recall affects Mighty Bliss…

Puff Bar this year remains the most popular brand of e-cigarette among young people, while Juul—the brand that helped make vaping popular among teens—has fallen off youngsters’ radar, according to new federal data. About 14% of U.S. high-school students—an estimated 2.1 million of them—said they had used e-cigarettes at least once during the past 30 days. An estimated 2.55 million total students, including those in middle school, had vaped during the past 30 days, according to the…

Photo: Spencer Platt (Getty Images)Juul’s 2022 just went from bad to worse. The e-cigarette maker somehow managed to narrowly survive (at least for now) a Federal Drug Administration effort to ban its products nationwide only to get smacked with a settlement worth nearly half a billion this week.On Tuesday, the company agreed to cough up $439 million to put to rest a two-year-old investigation led by 33 states and Puerto Rico seeking to determine whether the vaping giant markets its products to children and teens. In…

U.S. health regulators cleared use of retooled Covid-19 vaccines that target the latest versions of Omicron, in preparation for a fall booster campaign that could start within days.The action by the Food and Drug Administration on Wednesday permits people 12 years and older to receive an additional shot of the vaccine from Pfizer Inc. and BioNTech SE, and people 18 and older to receive a Moderna Inc. booster at least two months after…

The Food and Drug Administration is expected to authorize new Covid-19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans. Instead, the agency plans to assess the shots using data from other sources such as research in mice, the profiles of the original vaccines and the performance of earlier iterations of boosters targeting older forms of Omicron. “Real world evidence from the current mRNA Covid-19…

Moderna said it is ready to ship doses in September once it gets clearance. Photo: Desiree Rios for The Wall Street Journal…

A murky online market for abortion pills is thriving as some U.S. states tighten abortion restrictions.Dozens of websites state they ship abortion drugs anywhere in the U.S. without a prescription, which violates Food and Drug Administration rules. Most of the sites don’t clearly state who operates them or where they get the pills. The operator of one website said demand for abortion pills has surged since the Supreme Court removed constitutional protection for abortion in June. The sites, some registered overseas, are…

The Food and Drug Administration approved a gene therapy from Bluebird Bio Inc. that represents a potential cure for a rare blood disorder at a price of $2.8 million per patient, making it one of the nation’s most expensive drugs.The FDA on Wednesday cleared the treatment, Zynteglo, for patients who rely on regular blood transfusions because of a genetic disease called beta-thalassemia, which interferes with the production of hemoglobin, a protein in red blood cells that carries oxygen…

The Food and Drug Administration said it would allow some hearing aids to be sold over the counter, aiming to widen their availability in ways that could bring down costs and encourage development of better devices. Some 30 million adults in the U.S. have trouble with their hearing, the FDA said, but only about 20% use a hearing aid. High costs, challenges with access and social stigma discourage some people from using the devices, the FDA said. The devices can cost thousands of dollars…