FDA warns Evolved Ayuverdic Discoveries that its BioCBD+ products are legally considered to be misbranded unapproved new drugs.
The CDER Office of Prescription Drug Promotion warns AcelRx about false or misleading statements about its Dsuvia included in professional promotional...
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...
Bluebird Bio temporarily suspends studies of LentiGlobin gene therapy for sickle cell disease due to a reported unexpected serious adverse reaction.