FDA grants BeiGene a fast track designation for BGB-16673 and its use in adult patients with relapsed or refractory chronic lymphocytic leukemia or sm...
FDA clears an Insulet 510(k) for the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by those with Type 2 diabetes (ages 18 years and ...
A group of researchers find that about half of the over 500 AI devices allowed to enter the market since 2016 lack reported clinical validation data.
FDA turns up the pressure on iRhythm Technologies based on a second Form FDA-483 issued last month at the companys Cypress, CA manufacturing facility ...
FDA accepts for priority review a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide), for treating obesity due to Bardet-Biedl syndr...
Public Citizens Health Research Group calls on HHS Office of Inspector General to investigate allegations that retiring CDRH director Jeff Shuren fail...
CDER director Patrizia Cavazzoni says agency inspectors and reviewers are seeing deteriorating manufacturing quality in the facilities where biologics...
Federal Register notice: FDA makes available a final guidance entitled Electronic Submission Template for Medical Device De Novo Requests.
