The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors.
Similar Posts
Arterial Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire Exposure
Edwards recalls arterial cannulae due to risk of wire exposure that may cause serious patient harm.FDA’s ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience
FDA’s Center for Drug Evaluation and Research (CDER) recently accepted a new submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This submission is the first artificial intelligence-based and digital health technology-based project and the first proCreative Essences, Inc. – 710658 – 09/25/2025
CGMP/Finished Pharmaceuticals/AdulteratedComplex Innovative Trial Design Meeting Program
As displayed in the Federal Register notice on August 1, 2018, FDA is conducting a Complex Innovative Designs (CID) Meeting Program to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs, as highlighted in the sixth iteration oCDER Staff Member Shares Her Experience in a Breast Cancer Clinical Trial
She was overwhelmed, but she felt the trial was her best chance for a successful outcome.FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)
The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.
