Bluebird Bio temporarily suspends studies of LentiGlobin gene therapy for sickle cell disease due to a reported unexpected serious adverse reaction.
FDA cybersecurity advisor Jessica Wilkerson urges security controls wherever they can be built into hardware and software.
Federal Register notice: FDA has announced a 3/24 joint meeting of the Arthritis and the Drug Safety and Risk Management Advisory Committees to discus...
Federal Register notice: FDA announces a 3/5 Vaccines and Related Biological Products Advisory Committee meeting to discuss 2021 to 2022 influenza vac...
Federal Register notice: FDA announces a 3/23 Medical Devices Advisory Committees General and Plastic Surgery Devices Panel meeting that will discuss ...
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...