FDA grants MediciNova an orphan-drug designation for MN-166 (ibudilast) as adjunctive therapy to chemotherapy drug temozolomide for treating glioblast...
Congress fails to secure passage of an FDA spending bill last week and it is looking very likely that the agencys funding will be covered by a Continu...
FDA allows the de novo marketing of Bose Corp.s Bose Hearing Aid, the first hearing aid that enables users to fit, program and control the device with...
FDA approves a Zeiss PMA for ReLEx Smile to expand myopia treatment to patients with astigmatism.
Federal Register notice: FDA corrects the docket number in a 9/7 Federal Register notice announcing a draft guidance entitled Policy Regarding Quantit...
Federal Register notice: FDA submits to OMB an information collection extension for Electronic User Fee Payment Request Forms Form FDA 3913 and Form ...
A June FDA inspection of drug supplier McKesson results in a three-item Form 483 citing deficiencies with product tracing requirements.
FDA clears an Applied BioCode 510(k) for its BioCode Gastrointestinal Pathogen Panel and its use with the high throughput BioCode MDx-3000 molecular s...