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...
FDA clears a West Pharmaceutical Services 510(k) for its Vial2Bag Advanced 13mm admixture device.
A House of Representatives subcommittee asks FDA commissioner Robert Califf for a staff-level briefing on why it took so long for the agency to finall...
FDA issues a clinical hold on a Genentech multiple sclerosis clinical development program for fenebrutinib due to liver injury concerns.
FDA warns that it is continuing to advance its compliance activities associated with required clinical trial information postings in the ClinicalTrial...
