Merck says Phase 3 data from the KEYNOTE-598 study evaluating Keytruda (pembrolizumab) in combination with Bristol-Myers Squibbs Yervoy (ipilimumab) c...
FDA approves a Biogen supplemental BLA for an intramuscular injection route of administration for Plegridy (peginterferon beta-1a), indicated for trea...
FDA Review posts the Federal Register notices for the week ending 1/29/2021.
Janssen and Novavax report positive data from Phase 3 clinical trials involving each of their investigational Covid-19 vaccines.
FDA extends by three months the review of a Biogen BLA for aducanumab, indicated for treating Alzheimers disease.
FDA approves a Medtronic PMA for the DiamondTemp Ablation system for treating patients with recurrent, symptomatic paroxysmal atrial fibrillation who ...
FDA classifies as Class 1 a Penumbra recall of its Jet 7 Xtra Flex catheter due to its potentially becoming susceptible to distal tip damage during us...
FDA clears a Vertex Pharmaceuticals IND to proceed with a clinical trial for VX-880, an investigational cell therapy for treating Type 1 diabetes.