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...
Abiomed recalls its Impella Left Sided Blood Pumps because the devices Instructions for Use do not adequately address precautions to take when treatin...
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...
