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Two stakeholders recommend changes to an FDA draft guidance on treatment development for Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Blad...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...
Former FDA principal deputy commissioner Janet Woodcock joins the board of directors at Every Cure, a nonprofit organization that looks at repurposing...
Philips Respironics recalls (Class 1 device correction) its Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators regardin...
