With the Food and Drug Administration’s clearance, Pfizer and Moderna are set to begin shipping millions of doses. A third U.S. manufacturer, Novavax, expects its modified vaccine version to be available a little later.
FDA
The agency is expected to greenlight updated mRNA vaccines from Moderna and Pfizer/BioNTech that target a strain of the virus called KP.2, said the sources, who declined to be named because the timing information isn’t public.
Eli Lilly’s Kisunla was approved for mild or early cases of dementia caused by Alzheimer’s. It’s only the second drug that’s been convincingly shown to delay cognitive decline in patients, following last year’s approval of a similar drug from Japanese drugmaker Eisai.
The FDA sent a warning letter to Dollar Tree this month and placed Negasmart, the Ecuadorian distributor of WanaBana apple cinnamon pouches, under import alerts following the October 2023 recall of the products found to be contaminated with “extremely high” levels of lead and chromium.
The FDA and DOJ have legally barred about a half-dozen vaping companies for selling products that can appeal to youngsters, but many more manufacturers continue launching new products, primarily disposable vapes that can’t be refilled and are thrown in the trash.
Food and Drug Administration advisers voted unanimously that the drug’s ability to slow the disease outweighs its risks, including side effects like brain swelling and bleeding that will have to be monitored.
The Illinois Food Safety Act passed on a 37-15 bipartisan vote and will head to the state House for consideration. The banned chemicals are used in a wide variety of food products.
Some serious symptoms – including blurred vision, difficulty swallowing, shortness of breath, difficulty lifting one’s head and even hospitalizations – have been linked to the use of counterfeit Botox, the FDA said on Tuesday. As of Friday, a total of 19 women from nine states reported “harmful reactions.”
The lawsuit is the latest effort to force the government to ban menthols, which are disproportionately used by Black smokers and young people. It comes amid growing concerns from advocates that the federal plan could be derailed by election-year politics.
About 5,000 Illinoisans live with sickle cell disease, a gene defect most common in Black people that causes red blood cells to be misshapen and die off early, resulting in chronic fatigue and pain.
The drug’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain medical conditions would understand that they shouldn’t take the drug.
An estimated 17 million people in the U.S. have the type of food allergies that can cause rapid, serious symptoms, including severe, whole-body reactions that are potentially deadly.
A group of Illinois lawmakers have a proposal that would ban a handful of common additives in food made and sold in Illinois starting in 2027. California last year became the first state to ban the substances that are common in mass-produced and ultra-processed cereals, candies, salad dressings and sodas.
Regulators on Friday approved two gene therapies for sickle cell disease that doctors hope can cure the painful, inherited blood disorder that afflicts mostly Black people in the U.S.
The FDA has been officially exploring the possibility of a menthol ban for more than a decade. In July 2013, the FDA requested comments on preliminary research, data and evaluations with regard to the regulation of menthol.
Scientists have long identified an association between the use of hair-straightening chemical products with an increased risk of certain cancers. Research suggests that about 50% of products advertised to Black women contain these types of chemicals, compared with about 7% that are advertised to White women.
