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 ...
The decision will largely prevent compounding pharmacies from making and selling compounded versions of the drug in the next ...
Chimerix submitted a new drug application to the FDA seeking accelerated approval for dordaviprone to treat patients with ...
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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Sequana shares surge after FDA approval for aflapumpThe US Food and Drug Administration (FDA) has approved Sequana Medical’s alfapump for the treatment of recurrent or ...
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