Lytgobi is an FGFR inhibitor that received accelerated approval in 2022 to treat adults with previously treated, unresectable ...

The FDA has sent its first untitled letter of 2025, hitting Edenbridge Pharmaceuticals with a notice after assessing an exhibit booth panel’s compliance with the rules on promoting prescription ...

Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the “Letter”)[1] that was issued on February 3, 2025 to Edenbridge DBA Dexcel (“Dexcel”) over allegedly misleading ...

According to the FDA, an untitled letter cites violations that do not meet the threshold of regulatory significance for a warning notice. Unlike a warning, an untitled letter does not include a ...