FDA Roundup: February 28, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
PharmaLegacy Research LLC, dba. BTS Research Announces Expansion of their Headquarters & In Vitro Labs in their New San Diego Facility
PharmaLegacy Research LLC, dba. BTS Research Announces Expansion of their Headquarters & In Vitro Labs in their New San Diego Facility San Diego, CA February 1, 2025 San Diego, California…
FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease
The FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease. Source:…
FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin-aspart-szij), a biosimilar to its reference product Novolog (insulin aspart), to improve glycemic control in adults and children with diabetes mellitus.…
FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices
The FDA is alerting patients of a safety concern regarding diabetes devices that rely on a smartphone to deliver critical safety alerts. The FDA has received medical device reports in…