A Miami federal jury 5/18 acquits Tellus Clinical Research CEO Fidalgis Font and clinical study coordinator Julio Lopez in their alleged role of falsi...
FDA issues a safety alert on Novis-branded over-the-counter G-Supress DX Pediatric Drops because they may contain the incorrect product and cause pati...
Federal Register notice: FDA corrects a 7/13/2022 notice that announced the regulatory review period determination for Genentechs Enspryng (satralizum...
Aetion chief legal/regulatory officer and former FDA associate commissioner for policy Lowell Schiller says the agency should address the use of exter...
FDA grants Orlucent a breakthrough device designation for the companys Orlucent Skin Fluorescence Imaging System.
In an unprecedented decision, the DC District Court temporarily grants an attorneys motion to keep his identity secret in connection with a form FDA-4...
FDA approves a Braeburn Inc. NDA for Brixadi (buprenorphine) extended-release injection (subcutaneous) for treating moderate to severe opioid use diso...
Abbott reports new data from an IDE study of its AVEIR dual-chamber i2i leadless pacemaker, described as the worlds first.
