FDA issues an emergency use authorization for Cepheids point-of-care coronavirus diagnostic, the Cepheid Xpert Xpress SARS-CoV-2 test.
FDA green lights a Genentech randomized, double-blind, placebo-controlled Phase 3 clinical trial in collaboration with the Biomedical Advanced Researc...
Faced with many challenges to the healthcare system during the coronavirus outbreak, Eli Lilly decides to delay most new study starts and pauses enrol...
Federal Register notice: FDA publishes a final guidance entitled Submission of Plans for Cigarette Packages and Cigarette Advertisements.
Federal Register notice: FDA seeks comments on an information collection extension related to its guidance entitled Combination Products: How to Write...
Federal Register notice: FDA makes available a guidance entitled Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products Dur...
President Trump continues promoting the malaria drug chloroquine for immediate off-label use to combat the coronavirus.
FDA says today (3/23) is the first day that insulin and certain other biologic drugs transition to a different regulatory pathway.