The U.S. Food and Drug Administration said on Monday it has granted a national priority voucher to Johnson & Johnson's blood ...
FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.
Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental ...
The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, ...
U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective RSV treatments for infants would face fresh safety scrutiny following ...
The U.S. is considering allowing bemotrizinol, a highly effective UV filter used throughout Europe and Asia, in its sunscreen products for the first time ...
The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten ...
The FDA has revealed a set of measures designed to increase the availability of biosimilars in the U.S. and in turn reduce the price of biologic medicines after they lose patent protection. In new ...