Two stakeholders recommend changes to an FDA draft guidance on treatment development for Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Blad...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...
FDA orders a clinical hold on Kezar Life Sciences IND for zetomipzomib and its investigational use in treating lupus nephritis.
FDA awards a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection for treating moderate ...
AdvaMed says that as FDA begins receiving and reviewing diversity action plans, it should publicly disclose any key best practices it identifies.
