The Senate passes a minibus FY 2019 appropriations package that includes a $159 million (5%) boost for FDA over the FY 2018 enacted level.
Federal Register notice: FDA announces that it has revoked an Emergency Use Authorization issued to Zalgen Labs for the ReEBOV Antigen Rapid Test, int...
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.