FDA approves an Amphastar NDA for naloxone nasal spray for emergency treatment of an opioid overdose.
CDRH director Jeff Shuren takes the unusual step of addressing a companys criticism directed at his Centers alleged delay in granting an emergency use...
Federal Register notice: FDA amends the animal drug regulations to include application-related actions for new animal drug applications and abbreviate...
Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for certain medical devices intended for use during the Covid-19 p...
FDA accepts a Mesoblast BLA resubmission for remestemcel-L for treating children with steroid-refractory acute graft versus host disease.
An FDA safety update indicates that an agency literature review has found reports of 19 squamous cell carcinoma cases in the scar tissue (capsule) are...
Federal Register notice: FDA revokes the Emergency Use Authorizations issued for two Covid-19 diagnostics Babson Diagnostics for the Babson Diagnosti...
FDA will review a BioMarin sBLA to expand the approved achondroplasia treatment indication for Voxzogo to include children under age 5.
