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...
FDAs Oncology Center of Excellence and real-world evidence company Syapse renew a four-year agreement to collaboratively develop and implement specifi...
FDA clears a West Pharmaceutical Services 510(k) for its Vial2Bag Advanced 13mm admixture device.
