FDA clears a Sensus Healthcare 501(k) for its new SRT-100+, a next-generation Superficial Radiation Therapy solution, intended for use in treating non...
FDA clears a Hologic 510(k) for its Group B Streptococcus (GBS) assay on the Panther Fusion system.
Evolus resubmits a BLA for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as frown lines, in adult patients.
FDA asks two advisory committees to discuss how effective the transmucosal immediate-release fentanyl REMS is and how it can be improved to help fight...
Attorney Michelle Yeary finds things to appreciate and not agree with in a Florida federal court decision in a suit against Novartis.
FDA awards three cutting-edge manufacturing technology research grants.
Federal Register notice: FDA announces the fiscal year 2019 for prescription drug user fees.
Federal Register notice: FDA announces the fiscal year 2019 rates for the establishment and re-inspection fees related to entities that compound human...