FDA
The move comes nearly 35 years after the dye known as Red 3 was barred from cosmetics because of potential cancer risk.
The U.S. Food and Drug Administration spent more than 15 years crafting the guidelines, which are designed to do away with industry practices that downplay or distract viewers from risk information.
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.
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.