The U.S. Food and Drug Administration has approved the removal of black box warnings on several menopause hormone replacement ...
The warning label placed on all estrogen-based treatments since 2003 was based on an outdated and flawed government-funded ...
Vanda Pharmaceuticals’ seven-year ambition to score a coveted label expansion for sleep drug Hetlioz has taken an unusual turn, with the FDA acquiescing to a formal hearing on the matter. | The ...
The U.S. Food and Drug Administration has declined to approve an additional indication for Zynyz, a cancer therapy developed by Incyte (INCY) and MacroGenics (MGNX), due to issues found at a ...
By Michael Erman and Puyaan Singh March 5 (Reuters) - A senior FDA official called UniQure's experimental treatment for ...
Evidence suggests commercial health plans are more likely to delay specialty drug coverage decisions in response to FDA ...
The FDA proposes front-of-package "Nutrition Info boxes" to highlight saturated fat, sodium, and added sugars. The initiative aims to combat chronic diseases and promote healthier food choices. Large ...
Please provide your email address to receive an email when new articles are posted on . Safety labels will now explain risks associated with long-term use. Data from a pair of postmarketing ...
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 ...
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