FDA releases the form FDA-483 issued following an inspection at the Biocon sterile drug product manufacturing facility in Johor, Malaysia.
The House Energy and Commerce Committee asks FDA for a staff briefing about the presence of counterfeit copies of Novo Nordisks Ozempic (semaglutide) ...
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Two stakeholders recommend changes to an FDA draft guidance on treatment development for Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Blad...
