FDA says a Philips Respironics software correction for several ventilators was a Class 1 recall.
FDA releases the form FDA-483 with seven observations issued following an inspection at the Lorton, VA-based Annovex Pharma outsourcing facility.
FDA approves GE HealthCares Flyrcado (flurpiridaz F 18) injection, a positron emission tomography myocardial perfusion imaging agent for detecting cor...
FDA approves a Siemens Healthineers PMA for its tomosynthesis or three-dimensional breast imaging technology for its Mammomat B.brilliant mammography ...
The journal Science and other FDA watchers question why FDA does not place a clinical hold on Cassava Sciences investigational Alzheimers drug simufil...
The Justice Department says Liveyon founder and CEO John Kosolcharoen has been sentenced to 36 months in prison after pleading guilty to one count of ...
Fresenius Kabi recalls (Class 1 device correction) its Ivenix Infusion System Large Volume Pump software due to multiple software and cybersecurity vu...
Federal Register notice: FDA announces an 11/21 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review an AstraZeneca supplemental ...
