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 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...
FDA grants Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) 100 mg & 50 mg tablets for treating certain adult patients with chronic lymphoc...
University researchers say there is a pressing need to explore alternative methods for inspecting overseas and domestic drug manufacturing facilities ...
