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 ...