FDA grants a Taiho petition restricting generic forms of its Lonsurf cancer drug.
Researchers say FDA needs to strengthen enforcement against dietary supplements that contain prohibited ingredients.
FDA clears a Northeast Scientific 510(k) for reprocessing Philips Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter, which is used to tre...
FDA approves a Biotronik PMA for its Pulsar-18 T3 peripheral self-expanding stent system that is intended to improve implantation procedures for endov...
Two drug companies comment on an FDA draft guidance on antibacterial therapies.
Federal Register notice: FDA makes available a final guidance entitled Orange Book Questions and Answers.
Federal Register notice: FDA makes available a final guidance entitled Failure To Respond to an ANDA Complete Response Letter Within the Regulatory Ti...
Medexus Pharmaceuticals says its medac licensor has resubmitted its NDA for treosulfan, indicated for combination use with fludarabine as a preparativ...
