FDA approves Regeneron Pharmaceuticals Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis wh...
FDA sends an Integra LifeSciences a Warning Letter blocking PMA approvals due to quality systems issues at a Boston manufacturing facility.
Federal Register notice: FDA is seeking comments on an information collection entitled Export of Medical Devices; Foreign Letters of Approval.
Federal Register notice: FDA seeks comments on an information collection extension for Center for Devices and Radiological Health Appeals Processes.
Federal Register notice: FDA makes available a model Drug Facts label for nonprescription naloxone, indicated for treating opioid overdose.
The Trump Administration proposes a 7% boost ($419 million) in FDAs 2020 budget, which includes more than $220 million to continue advancing new initi...
CytoDyn seeks fast track status for leronlimab (PRO 140) after it showed a significant reduction in the volume of human breast cancer tumor metastasis...
FDA grants Alcyone Lifesciences a breakthrough device designation for its ThecaFlex DRx System, an implantable subcutaneous port and intrathecal cathe...