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☆ Why increasingly popular Zyn nicotine pouches concern health experts
▼ + stars: | 2024-04-03 | by ( Taylor Nicioli | ) edition.cnn.com time to read: +10 min

Are nicotine pouches better than vaping? Zyn, among other brands of nicotine pouches such as Rogue, On! However, FDA officials have allowed the nontobacco nicotine product to stay on the market while the application is under review. Nicotine pouches have varying degrees of nicotine strength; 3 or 6 milligrams per pouch is most common, but some brands have pouches that contain upward of 28 milligrams. What’s more, the Zyn nicotine pouches come in a variety of flavors, including cool mint, wintergreen, coffee and cinnamon, that could be appealing to younger people.

Persons: Philip Morris, Chuck Schumer, ”, Kecia Christensen, “, ’ ”, Christensen, Philip Morris International’s, ” Philip Morris, Meghan Moran, ” Moran, Brian King, Yanfang Ren, ” Ren, Moran Organizations: CNN, Philip Morris International, Facebook, Federal Trade Commission, Food and Drug Administration, American Cancer Society, Nebraska Medicine, FDA, National Cancer Institute, CDC, Centers for Disease Control, ” Philip Morris International, Swedish, Johns Hopkins Bloomberg School of Public Health, Tobacco Survey, FDA’s Center for Tobacco Products, University of Rochester Eastman Institute for Oral Health, Philip Locations: United States, ”, Baltimore, New York, Mayo

The FDA approved tirzepatide for weight loss under the brand name Zepbound. It has been available as Mounjaro for type 2 diabetes since 2022 and had increasingly been used "off-label" for weight loss while the obesity approval was pending. Zepbound will be available in the U.S. by the end of the year at a list price of $1,059.87 a month, according to Lilly. That compares with a list of $1,349 per-package for Novo Nordisk's (NOVOb.CO) wildly popular weight-loss drug Wegovy. After Wednesday's FDA approval, Lilly can now promote the drug for weight loss.

Persons: Eli Lilly, Mike Segar, Eli Lilly's, ” John Sharretts, Lilly, Morningstar, Damien Conover, Conover, drugmaker, Robert Kushner, Mounjaro, Patrick Wingrove, Leroy Leo, Bhanvi, Shinjini Ganguli, Bill Berkrot Organizations: Company, REUTERS, U.S . Food, Drug Administration, U.S, FDA, FDA’s Center, Drug, Research, Novo Nordisk's, Reuters, Northwestern University Feinberg School of Medicine, Thomson Locations: Branchburg , New Jersey, U.S, Indianapolis, United States, New York, Bengaluru

The Food and Drug Administration on Tuesday granted emergency use authorization to the updated COVID-19 vaccine from Novavax, marking the third new coronavirus shot that will be made available to the public ahead of the winter and the only not produced with messenger RNA technology. FDA authorized the shot for people ages 12 and older just weeks after shots from Moderna and Pfizer rolled out. “Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. Some individuals are skeptical of the new technology, instead opting for Novavax’s more traditional use of protein-based technology. “In the coming days, individuals in the U.S. can go to major pharmacies, physicians’ offices, clinics and various government entities to receive an updated Novavax vaccine.”

Persons: “, ” Peter Marks, ”, John Jacobs Organizations: Drug Administration, FDA, Moderna, Pfizer, FDA’s, Biologics, Research, Health, Covid Locations: U.S

The Food and Drug Administration on Monday authorized updated COVID-19 shots that could roll out as soon as this week. “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. The fall booster shot campaign comes as the U.S. sees its seventh straight week of rising COVID-19 hospitalizations. COVID-19 deaths appear to be rising slightly, but the provisional data from the CDC is prone to amendments and delays.

Persons: ”, Peter Marks Organizations: Drug Administration, FDA’s, Biologics, Centers for Disease Control, EG Locations: U.S

☆ FDA approves first over-the-counter birth control pill
▼ + stars: | 2023-07-13 | by ( Carma Hassan | ) edition.cnn.com time to read: +3 min

CNN —The US Food and Drug Administration on Thursday approved the birth control pill Opill to be available over-the-counter — the first nonprescription birth control pill in the United States. Opill is expected to be available over-the-counter in stores by the end of March 2024. The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers. A recent study showed that it has become harder for women to access reproductive health care services more broadly — such as routine screenings and birth control — in recent years. About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017.

Persons: “, Patrizia Cavazzoni, “, ”, Frederique Welgryn, Opill, Welgryn, Perrigo, Dr, Sanjay Gupta, —, Meg Tirrell Organizations: CNN, Food and Drug Administration, FDA’s Center, Drug, Research, FDA, CNN Health Locations: United States, U.S

☆ FDA fines e-cigarette makers for selling products illegally in ‘wakeup call’ to tobacco manufacturers
▼ + stars: | 2023-02-22 | by ( Jen Christensen | ) edition.cnn.com time to read: +3 min

BAM Group LLC, Great American Vapes LLC, The Vapor Corner Inc and 13 Vapor Co LLC did not immediately respond to CNN’s request for comment. “Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Dr. Brian King, director of the FDA’s Center for Tobacco Products. “These actions should be a wakeup call that all tobacco product manufacturers – big or small – are required to obey the law,” King said. The agency can seize products, file injunctions to not sell the products, and the companies can face criminal prosecutions. “With these fines, FDA is finally speaking a language these manufacturers understand,” Sward told CNN.

☆ FDA approves $3.5 million treatment for hemophilia, now the most expensive drug in the world
▼ + stars: | 2022-11-23 | by ( Deidre Mcphillips | ) edition.cnn.com time to read: +2 min

CNN —The US Food and Drug Administration on Tuesday approved Hemgenix, a new drug to treat hemophilia. Manufacturer CSL Behring set the price at $3.5 million per treatment, making it the most expensive drug in the world. In a recent cost-effectiveness analysis of the drug, weighing health benefits against offset costs, ICER suggested that a fair price for the drug to be between $2.93 million and $2.96 million. According to an analysis by GoodRx, the most expensive drug in the US previously was Zolgensma, which was approved by the FDA in 2019 to treat spinal muscular atrophy and priced at $2.1 million for a course of treatment. FDA approved Hemgenix based on safety and effectiveness evaluated in two studies of about 60 adult men.

☆ Lab-grown meat is OK for human consumption, FDA says
▼ + stars: | 2022-11-17 | by ( Katie Hunt | ) edition.cnn.com time to read: +3 min

CNN —The US Food and Drug Administration has given a safety clearance to lab-grown meat for the first time. Upside Foods, a California-based company that makes meat from cultured chicken cells, will be able to begin selling its products once its facilities have been inspected by the US Department of Agriculture. Advocates hope that cultured meat will reduce the need to slaughter animals for food and help with the climate crisis. “At scale, cultivated meat is projected to use substantially less water and land than conventionally-produced meat.”Although not technically an approval, the FDA said that a thorough pre-market consultation process had been completed. The clearance only applies to food made from cultured chicken cells by Upside, but the statement said the FDA “is ready to work with additional firms developing cultured animal cell food.”

☆ More than 3 million middle and high school students reported using tobacco in 2022
▼ + stars: | 2022-11-10 | by ( Raenu Charles | ) edition.cnn.com time to read: +3 min

For the ninth consecutive year, e-cigarettes were the most commonly used tobacco product among youth – about 2.55 million reported using them – followed by cigars, cigarettes and smokeless tobacco. Non-Hispanic White youth reported the most e-cigarette use, 11%, while Black youth reported the most combustible tobacco product use, 5.7%, including cigar use, 3.3%. “Commercial tobacco product use continues to threaten the health of our nation’s youth, and disparities in youth tobacco product use persist,” Deirdre Lawrence Kittner, director of CDC’s Office on Smoking and Health, said in a statement. Researchers call for continued surveillance of all tobacco products, sustained implementation of tobacco control strategies and FDA regulation of tobacco products. However, with an ever-changing tobacco product landscape, there’s still more work to be done,” Brian King, director of the FDA’s Center for Tobacco Products, said in a statement on Thursday.

☆ Updated Covid-19 boosters offer protection, but new studies suggest they don't offer an edge against Omicron
▼ + stars: | 2022-10-26 | by ( Brenda Goodman | ) edition.cnn.com time to read: +13 min

Similar immune responsesThe studies have important limitations, and they aren’t the final word on the updated boosters. In Barouch’s study, antibody concentrations were 15 times higher after the original boosters, rising from 184 to 2,829. They were 17 times higher after the updated shots, jumping from 211 to 3,693. After waiting the recommended three months since his last Covid-19 infection, President Joe Biden got an updated booster Tuesday and urged eligible Americans to do the same. Worobey says that when the strains are combined as they are in the updated boosters, they actually end up competing.

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