Vinay Prasad is back at the Food and Drug Administration (FDA), picking up where he left off just two weeks ago. He's in charge of vaccines, gene therapies, and blood products again. The FDA asked him to come back, but it's not clear if he'll keep his other big job as the agency's top medical and sc
A popular snack is causing concern. Freeze-dried fruit variety packs from Sam’s Club are being pulled off the shelves. The reason? A harmful bacteria called listeria might be in them. The company, Doehler Dry Ingredient Solutions, LLC, found this bacteria during their own tests. So far, no one has g
The FDA is stepping up its game against a specific chemical found in kratom products. This compound, 7-hydroxymitragynine, is popping up in energy drinks, gummies, and supplements sold in convenience stores. Health officials are sounding the alarm, suggesting a nationwide ban. Kratom, a plant from
U. S. health authorities are sounding the alarm about a specific chemical found in kratom, a plant from Southeast Asia. This chemical, 7-hydroxymitragynine, is popping up in energy drinks, gummies, and supplements sold in convenience stores. The Food and Drug Administration (FDA) is recommending a n
In a surprising turn of events, Sarepta Therapeutics has chosen to defy the FDA's request to stop distributing its gene therapy drug, Elevidys. This decision comes after three patient deaths linked to the treatment. The FDA has expressed serious concerns about the safety of the drug and has asked Sa
Moderna's latest flu vaccine trial results are in, and they're looking good. The company's experimental mRNA-based flu shot showed a stronger immune response than the standard flu vaccine currently in use. This is big news, especially since Moderna is also working on a combo shot that targets both f
A major breakthrough in HIV prevention has just been approved by the FDA. The drug, called Yeztugo, is based on research done by a biochemist from the University of Utah. This drug is special because it can protect people from HIV for a long time, up to six months. It works by stopping the virus fro
A well-known children's cough syrup has been pulled from the market. The US Food and Drug Administration made this announcement. Medtech Products, the maker of Little Remedies Honey Cough Syrup, has taken five batches off the shelves. This syrup is meant for kids aged 1 and up. The problem? It
The world of drug and biologic product regulation is undergoing a significant shift. Generative artificial intelligence (AI) is at the heart of this change. It is making it easier and faster to find important information. This is not just about speed. It is about making the process of regulation mor
The US Food and Drug Administration demands that e-cigarettes carry a single text warning about nicotine addiction. This rule is in place, but there is a lack of evidence proving that these warnings are the most effective approach. There is a pressing need to explore whether these text warnings are
