FDA publishes a guidance to assist applicants in incorporating heart rate-corrected (QTc) interval of prolongation-related information in the labeling...
A Washington, DC, federal judge rules that FDA acted unlawfully when it denied a priority review voucher to Sun Pharma and its drug Sezaby, the first ...
Weeks into his new appointment, CDER director Richard Pazdur files paperwork to retire by the end of the month.
FDA issues an early alert concerning certain Abbott Diabetes Care glucose monitor sensors, warning patients and healthcare providers about potentially...
Government prosecutors win guilty conviction against Hi-Tech Pharmaceuticals CEO and twice-convicted felon Jared Wheat for orchestrating a years-long ...
FDA issues a safety alert after Becton Dickinson recently recalled (Class 1 device correction) certain Alaris Pump Modules if they have been dropped o...
Leading vaccine experts sharply criticize a new FDA memo that claims ten children died after and because of receiving Covid-19 vaccines between 2021 a...
Belite Bio reports positive topline results from the global Phase 3 DRAGON trial of tinlarebant, marking the first successful pivotal trial in patient...
