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
CNN — The U.S. Food and Drug Administration amended the terms of its emergency use authorizations for the Pfizer and Moderna bivalent vaccines on Tuesday, allowing people ages 65 and older and certain people with weakened immunity to get additional doses before this fall’s vaccination campaigns. The bivalent vaccines made by Pfizer and Moderna carry … Read more
Our application process was designed for common ailments, but roughly 30 million Americans suffer from uncommon ones. Source link