Medpage Today on MSN9d
FDA Staff Not Quite Sold on Sotagliflozin for T1D Patients With CKDFDA staff raised familiar safety concerns about sotagliflozin as a treatment for type 1 diabetes (T1D) as the agency again ...
After multiple rejections, Lexicon Pharmaceuticals is inching toward an FDA decision date next month for its adjunct type 1 ...
On Halloween, Lexicon was haunted again as an FDA advisory committee voted 11-3 to reject Zynquista as an accompanying ...
Sotagliflozin is an oral dual sodium-glucose co-transporter types 1 and 2 (SGLT1/SGLT2) inhibitor. The FDA panel voted against the approval of sotagliflozin for patients with type 1 diabetes and ...
Lexicon (LXRX) announced the peer-reviewed Journal of American Society of Nephrology, or JASN, has published a research paper analyzing the ...
While an FDA advisory committee saw signals of efficacy for Lexicon Pharmaceuticals’ sotagliflozin, the panel of external ...
Lexicon retains sole commercialization rights for sotagliflozin in all indications in the United States and Europe. Sotagliflozin was approved by the U.S. Food and Drug Administration in May 2023 ...
Q3 2024 Earnings Conference Call November 6, 2024 8:30 AM ETCompany ParticipantsBill Szablewski - Head of Capital ...
Data were limited for patients with eGFR 60, therefore definitive conclusions on the benefits and risks in this subgroup could not be made. At a meeting of the Food and Drug Administration’s ...
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