Sentec/Percussionaire recalls (Class 1 device correction) its Phasitron 5 In-Line Valve to update use instructions due to an increase in reports of pa...
University researchers worldwide urge FDA to reevaluate its use of a Boxed Warning in labeling for youth antidepressants after studies show it is asso...
FDA reviewers appear unconvinced that a Stealth BioTherapeutics NDA for elamipretide, a mitochondria-targeted therapy for treating Barth syndrome, con...
FDA grants a de novo marketing authorization for over-the-counter Healgen Rapid Check Covid-19/Flu A&B Antigen Test.
FDA releases the transcript from a two-day workshop held in conjunction with NIH on developing clinical outcome assessments to demonstrate the risks a...
Two stakeholders recommend changes to an FDA draft guidance on treatment development for Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Blad...
FDA warns Indias MMC Healthcare about CGMP violations in its production of finished drugs.
The American Hospital Association asks the Biden Administration to require FDA to take immediate actions to increase the supply of intravenous (IV) so...
