FDA approves a Kiniksa Pharmaceuticals NDA for Arcalyst (rilonacept) injection to treat recurrent pericarditis in adults and children 12 years and old...
FDA announces a 5/4 virtual public meeting entitled Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices.
FDA accepts a Bristol Myers Squibb NDA for mavacamten, an investigational allosteric modulator of cardiac myosin for treating patients with symptomati...
CBERs Office of Compliance and Biologics Quality sends Reno Integrative Medical Center an untitled letter after reviewing the institutions Web site an...
An FDA safety alert advises that health care professionals not use Becton, Dickinsons ChloraPrep 3 mL applicators due to microbial contamination risks...
FDA acting commissioner Janet Woodcock says the government has stopped distributing a Lilly monoclonal antibody in three western states because of a p...
Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviate...
CDER creates a new Web page to house scientific review documents supporting emergency use authorizations for drug and biological therapeutic products,...