[ Price : $8.95]
Federal Register notice: FDA announces the withdrawal of two Mammography Quality Standards Act (MQSA) alternative standards due to...[ Price : $8.95]
FDA grants BeiGene a fast track designation for BGB-16673 and its use in adult patients with relapsed or refractory chronic lympho...[ Price : $8.95]
FDA clears an Insulet 510(k) for the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by those with Type 2 diabetes...[ Price : $8.95]
A group of researchers find that about half of the over 500 AI devices allowed to enter the market since 2016 lack reported clinic...[ Price : $8.95]
FDA turns up the pressure on iRhythm Technologies based on a second Form FDA-483 issued last month at the companys Cypress, CA man...[ Price : $8.95]
FDA accepts for priority review a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide), for treating obesity due t...[ Price : $8.95]
Public Citizens Health Research Group calls on HHS Office of Inspector General to investigate allegations that retiring CDRH direc...[ Price : $8.95]
CDER director Patrizia Cavazzoni says agency inspectors and reviewers are seeing deteriorating manufacturing quality in the facili...