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...
Federal Register notice: HHS postpones, pending judicial review, the effective date of a final rule entitled Securing Updated and Necessary Statutory ...
FDA approves a Janssen NDA for Ponvory (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor modulator for treating adults with re...
FDA approves a Kiniksa Pharmaceuticals NDA for Arcalyst (rilonacept) injection to treat recurrent pericarditis in adults and children 12 years and old...
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,...