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...
FDA Review posts the Federal Register notices for the week ending 2/8/2019.
FDA grants Genentech accelerated approval for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable ...
FDA accepts for priority review a Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately con...