Federal Register proposed rule: FDA proposes to amend its regulation that defines biological product to incorporate changes made by the Biologics Pric...
Federal Register notice: FDA issues a priority review voucher to Novimmune for its approved rare pediatric disease product application for Gamifant (e...
Federal Register notice: FDA determines that Akorns ICGreen (indocyanine green for injection), 10 milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, wa...
FDA issues a final rule to update procedures for classifying and reclassifying medical devices to conform to change in the FDA Safety and Innovation A...
FDA clears a Tangible Science 510(k) for its daily disposable silicone hydrogel contact lens coated with a modified formula of Tangible Hydra-PEG, whi...
FDA grants Gibson Oncology a Rare Pediatric Disease Designation for LMP-400, the companys novel small molecule topoisomerase 1inhibitor for treating E...
The Center for Veterinary Medicine works with Pfizer to keep a supply of injectable opioids available in the U.S. veterinary market.
Stakeholders praise an FDA draft guidance on use of minimal residual disease as a biomarker in developing drugs to treat blood cancers.