The agencies are charged with making decisions that touch the lives of every American and are the source of crucial ...
First recommended by a Trump-appointed FDA leader, multiple administrations have collaborated to snuff out this issue that ...
The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility ...
CHARLESTOWN, Mass. - Solid Biosciences Inc. (NASDAQ:SLDB), a $130.65 million market cap biotechnology company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) ...
Fast-track status will allow Solid Biosciences to have more frequent meetings with the FDA throughout the treatment-development process and, potentially, get the product to patients faster than would ...
Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation ...
The U.S. Food and Drug Administration (FDA) is demanding increased, in-your-face food transparency when it comes to nutrition ...
The FDA is the leading science-based consumer protection agency in the world. Three former senior officials write about what ...