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...
FDA approves Regeneron Pharmaceuticals Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis wh...
FDA Review posts the Federal Register notices for the week ending 2/8/2019.
Federal Register notice: FDA seeks comments on an information collection extension for Center for Devices and Radiological Health Appeals Processes.
Federal Register notice: FDA seeks comments on a new information collection for Proposed Suffix for the Proper Name of a Biological Product.