GE HealthCare recalls its TruSignal SpO2 Sensors due to malfunction issues that may reduce defibrillation energy or expose patients to unintended volt...
FDA issues a draft guidance to help sponsors design pivotal clinical trials for innovative medical devices to treat opioid use disorder.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...
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...
