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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...[ Price : $8.95]
FDA clears a West Pharmaceutical Services 510(k) for its Vial2Bag Advanced 13mm admixture device.[ Price : $8.95]
FDA issues a clinical hold on a Genentech multiple sclerosis clinical development program for fenebrutinib due to liver injury con...[ Price : $8.95]
FDA warns that it is continuing to advance its compliance activities associated with required clinical trial information postings ...