FDA clears an UltraSight 510(k) for its artificial intelligence-powered ultrasound guidance technology.
Federal Register notice: FDA makes available a final guidance entitled Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommend...
Federal Register notice: FDA makes available a final guidance entitled CDERs Program for the Recognition of Voluntary Consensus Standards Related to P...
FDA issues a draft guidance to help sponsors design pivotal clinical trials for innovative medical devices to treat opioid use disorder.
Reuters says FDA documents show sterility issues at the Catalent facility in Brussels, Belgium, that fills Wegovy syringes for Novo Nordisk.
FDA says it wont review the BioHaven NDA for toriluzole to treat spinocerebellar ataxia because a Phase 3 trial did not meet its primary endpoint.
Florida governor Ron DeSantis says that if he is elected president he might name avowed anti-vaxxer Robert F. Kennedy, Jr., to head either FDA or the ...
Sen. Gary Peters introduces bipartisan legislation he says will help ease drug shortages by requiring HHS to award contracts that prioritize U.S. gene...
