Archive for February 2025
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
Read MorePharmaLegacy 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 — BTS Research, a leading provider of in vitro and in vivo preclinical drug development services, announces the expansion of its San Diego operations. The…
Read MoreFDA 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 Press Releases
Read MoreFDA 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. Source: FDA Press Releases
Read MoreFDA 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 which users report these alerts are not being delivered or not being heard. Source: FDA Press Releases
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