A recent conference panel describes how FDA Product Jurisdiction Officers provide one-stop communication and coordination services for potential combi...
CDER researchers say their statistical analysis demonstrates that switching between biosimilars and their reference products is not associated with ma...
FDA accepts for priority review an ImmunoGen supplemental BLA to convert the accelerated approval of Elahere (mirvetuximab soravtansine-gynx) to full ...
A lengthy Bloomberg News article outlines concerns the Defense Department, health systems, and Congress have about FDAs ability to evaluate the safety...
Roche says it will discuss with FDA and other health authorities positive results from the Phase 3 INAVO120 study of inavolisib in combination with pa...
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices; Device Tracking 21 CFR Part 821.
An FDA untitled letter cautions Novartis that its manufacturing facility in Morris Plains, NJ, is deviating from current good manufacturing practices ...
FDA grants ABK Biomedical a breakthrough device designation for its proposed Eye90 microspheres and its use in treating patients living with unresecta...
