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 ...
The House approves legislation reauthorizing the FDA Pediatric Rare Disease Priority Review Voucher program and giving the agency the authority to ord...
FDA publishes a draft guidance on streamlined nonclinical safety studies for monoclonal antibodies.
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...
