NEWYou can now listen to Fox News articles! FIRST ON FOX: The Food and Drug Administration (FDA) rolled out a new platform, backed by artificial intelligence, that will streamline publicly accessible reporting of negative or unexpected health effects linked to medicines, vaccines, cosmetics, animal food and other consumer products. The FDA Adverse Event Monitoring System … Read more
Novo Nordisk, the pharmaceutical company behind Ozempic, has received a warning letter from the U.S. Food and Drug Administration over issues with its procedures for reporting potential side effects of the flagship diabetes drug, which is also prescribed for weight loss. In the letter, dated March 5, the FDA cited three deaths among patients receiving … Read more
WASHINGTON — The Food and Drug Administration on Tuesday approved a generic medication for a rare brain disorder, while walking back suggestions by President Donald Trump and other administration officials that the drug showed great promise for people with autism. The agency said it approved leucovorin for children and adults with a genetic condition that … Read more
The Food and Drug Administration on Tuesday announced a new approved use for the drug leucovorin, a synthetic form of vitamin B9 that the Trump administration has touted as a treatment for autism symptoms. But the new approval is not for autism — it’s for cerebral folate deficiency, a rare neurological condition characterized by low … Read more
The Food and Drug Administration’s embattled vaccine chief, Dr. Vinay Prasad, is once again leaving the agency — the second time in less than a year that he’s departed after controversial decisions involving the review of vaccinations and specialty drugs for rare diseases. FDA Commissioner Marty Makary announced the news to FDA staff in an … Read more
WASHINGTON — The Food and Drug Administration’s embattled vaccine chief, Dr. Vinay Prasad, is once again leaving the agency — the second time in less than a year that he’s departed after controversial decisions involving the review of vaccinations and specialty drugs for rare diseases. FDA Commissioner Marty Makary announced the news to FDA staff … Read more
The progress we have seen in the first year of this administration is notable. Source link
WASHINGTON — The Food and Drug Administration’s top drug regulator, Dr. Tracy Beth Hoeg, is working to hire a researcher and friend who wants the agency to add new warnings to antidepressants about unproven pregnancy risks, The Associated Press has learned. Dr. Adam Urato, a maternal-fetal medicine specialist and critic of antidepressant safety, is pressing … Read more
The Continent green-lights Moderna’s combo flu and Covid shot. Source link
Commissioner Marty Makary talks about accelerated cures while biologics chief Vinay Prasad quietly scuttles them. Source link