FDA approves an expanded indication for Novartis Entresto (sacubitril/valsartan) to reduce the risk of cardiovascular death and hospitalization for he...
The Hill details how a group of outside scientists came together to help former FDA commissioner Stephen Hahn resist political pressure and back the a...
CDRHers Jeffrey Shuren and Timothy Stenzel describe lessons learned from the experience with Covid-19 serology tests.
FDA says it is difficult to draw conclusions on the safety and efficacy of the Lutonix 014 drug-coated balloon PTA catheter.
FDA approves a Pfizer supplemental BLA for Panzyga (immune globulin intravenous [human] ifas 10% liquid preparation) to treat adult patients with chr...
FDA releases its latest batch of Warning Letters that include Evolved Ayurvedic Discoveries and AcelRx Pharmaceuticals.
FDA approves a Shockwave Medical PMA for its Intravascular Lithotripsy to treat severely calcified coronary artery disease.
Bluebird Bio temporarily suspends studies of LentiGlobin gene therapy for sickle cell disease due to a reported unexpected serious adverse reaction.