Merck says its investigational V116 21-valent pneumococcal conjugate vaccine hit key immunogenicity and safety endpoints in two Phase 3 trials in adul...
House GOP leadership delay a floor vote on FDAs fiscal year 2024 budget bill until lawmakers return from their August recess.
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 clears a Shenzhen Superbio 510(k) for a point-of-care instrument intended for the qualitative detection of fentanyl in human urine.
Federal Register notice: FDA announces a 9/27 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to discuss a BrainStorm Therapeutics sup...
Federal Register notice: FDA permanently debars Diana Daffin from providing services in any capacity to a person that has an approved or pending drug ...