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CDER researchers say their statistical analysis demonstrates that switching between biosimilars and their reference products is no...[ Price : $8.95]
FDA accepts for priority review an ImmunoGen supplemental BLA to convert the accelerated approval of Elahere (mirvetuximab soravta...[ Price : $8.95]
A lengthy Bloomberg News article outlines concerns the Defense Department, health systems, and Congress have about FDAs ability to...[ Price : $8.95]
Roche says it will discuss with FDA and other health authorities positive results from the Phase 3 INAVO120 study of inavolisib in...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices; Device Tracking 21 CFR Pa...[ Price : $8.95]
An FDA untitled letter cautions Novartis that its manufacturing facility in Morris Plains, NJ, is deviating from current good manu...[ Price : $8.95]
FDA grants ABK Biomedical a breakthrough device designation for its proposed Eye90 microspheres and its use in treating patients l...[ Price : $8.95]
FDAs Oncology Center of Excellence and real-world evidence company Syapse renew a four-year agreement to collaboratively develop a...