FDA issues an early alert warning about a potentially high-risk defect in certain Fresenius Kabi Ivenix large volume pump primary administration sets.
Johnson & Johnson discontinues its Auτonomy Phase 2b Alzheimers study after interim data showed its experimental antibody posdinemab failed to pr...
FDA cites PharmaTher over alleged misleading promotional claims for its generic ketamine.
Novo Nordisk says data from two global Phase 3 trials of semaglutide (Ozempic and Wegovy) have failed to slow clinical progression in adults with earl...
Three Harvard medical professors raise concerns over FDAs review voucher program that they say could politicize drug approvals and undermine scientifi...
FDA posts a Federal Register notice finalizing the withdrawal of Intercept Pharmaceuticals Ocaliva (obeticholic acid) from the U.S. market for treatin...
FDA issues a correction notice for NOxBOX Ltd.s NOxBOXi Nitric Oxide Delivery System after reports of dosing fluctuations when the device is used with...
FDA approves Mercks checkpoint inhibitor Keytruda (pembrolizumab) in combination with Astellas and Pfizers antibody drug conjugate Padcev as a periop...