The agency recently sent a warning letter to the company's CEO, Valentina Milanova, noting that an inspection of the ...
Lexicon Pharmaceuticals has already thrown in the towel on its commercial efforts after a years-long uphill battle to get its ...
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and ...
“As we entered 2024, the Company had three primary goals in our quest to ensure we are ready for the successful commercial launch of LIBERTY in 2025: 1) complete FDA 510(k) submission ...