The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
The decision follows a September meeting of the agency's Gastrointestinal Drugs Advisory Committee, which agreed that the ...
While an FDA advisory committee saw signals of efficacy for Lexicon Pharmaceuticals’ sotagliflozin, the panel of external ...
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FDA Panel Rejects SGLT1/2 Inhibitor for Type 1 DiabetesThe FDA rejected sotagliflozin 5 years ago for the same indication but for the broader population of adults with T1D, due to ...
Announced Exclusive Licensing Agreement with Viatris for Sotagliflozin in all Markets Outside of the U.S. and EuropeCompleted ZYNQUISTA™ FDA ...
Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by ...
On Halloween, Lexicon was haunted again as an FDA advisory committee voted 11-3 to reject Zynquista as an accompanying ...
After multiple rejections, Lexicon Pharmaceuticals is inching toward an FDA decision date next month for its adjunct type 1 ...
An FDA advisory committee voted Thursday that it didn’t believe the benefits of Lexicon's (LXRX) diabetes drug sotagliflozin ...
The Albanese Government is ensuring patients get access to life changing medications and treatments as quickly as possible.Due to an unprecedented ...
BOSTON (AP) — The NHLPA will form an advisory committee to help hockey players better understand ... at the annual gala for ...
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