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notice: FDA determines that Exela Pharma Sciences diltiazem HCl in dextrose, 125mg/125mL and 250mg/250mL were not withdrawn from sale...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 ...
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...
