FDA approves Abbotts new Precision Plus spinal cord stimulation system.
BioMarin Pharmaceutical says it will resubmit by the end of September its BLA for hemophilia A gene therapy Roctavian (valoctocogene roxaparvovec) gen...
FDA commissioner Robert Califf says there are no new questions on the recently submitted Covid-19 booster vaccines and the agency will not need an adv...
Three stakeholders comment on an FDA draft guidance on rescinding breakthrough therapy designations.
FDA approves a Pharmacyclics supplemental NDA for Imbruvica (ibrutinib) for certain pediatric patients over one year of age with chronic graft versus ...
FDA publishes drug safety-related labeling changes for Gleevec and Rapamune.
A House Select Subcommittee on the Coronavirus Crisis report details evidence of what it sees as inappropriate Trump administration pressure on FDA ov...
Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Devices; Humanitarian Use Devices (HUD) 21 CFR part 814...
