FDA approves Amgens Blincyto (blinatumomab) for treating adult and pediatric patients with CD19-positive Philadelphia chromosome-negative B-cell precu...
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...
Federal Register notice: FDA determines that Exela Pharma Sciences diltiazem HCl in dextrose, 125mg/125mL and 250mg/250mL were not withdrawn from sale...
Federal Register notice: FDA announces the withdrawal of two Mammography Quality Standards Act (MQSA) alternative standards due to updated MQSA regula...
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 ...
