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 ...
Chimerix submitted a new drug application to the FDA seeking accelerated approval for dordaviprone to treat patients with ...
The FDA announced Monday it has begun collecting samples of aged raw cow's milk cheese to test for bird flu as the U.S. battles an outbreak of the virus.
After plugging billions into its manufacturing network to meet rampant demand for Mounjaro and Zepbound, Eli Lilly is looking ...
A new drug application seeking the accelerated approval of dordaviprone forrecurrent for H3K27M-mutant diffuse glioma ...
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 ...
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