As required by the PDUFA 7 agreement, FDA publishes a framework for how it will implement a multifaceted program for using digital health technologies...
FDA adds the Xtrava Health SPERA Covid-19 test to the list of tests expected to have a reduced performance with certain Covid-19 Omicron sub-variants.
FDA-funded research finds that unibody endografts are not non-inferior to non-unibody devices, leading to updated FDA labeling.
FDA reminds patients and healthcare providers about risks associated with recalled Exactech replacement joint devices that were packaged in defective ...
Regeneron and Sanofi say an investigational Phase 3 trial of Dupixent in some COPD patients met all key primary and secondary endpoints.
The Government Accountability Office reports on regenerative medicine and advanced therapies workforce and education/training needs.
A new White House Office of Science and Technology Policy (OSTP) report lists 10 bold goals for the U.S. biotechnology and biomanufacturing.
CDRH director Jeff Shuren tells an Alliance for Stronger FDA Webinar that cybersecurity is one of the biggest concerns that keeps him up at night.
