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FDA approves an Amphastar NDA for naloxone nasal spray for emergency treatment of an opioid overdose.[ Price : $8.95]
CDRH director Jeff Shuren takes the unusual step of addressing a companys criticism directed at his Centers alleged delay in grant...[ Price : $8.95]
Federal Register notice: FDA amends the animal drug regulations to include application-related actions for new animal drug applica...[ Price : $8.95]
Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for certain medical devices intended for use d...[ Price : $8.95]
FDA accepts a Mesoblast BLA resubmission for remestemcel-L for treating children with steroid-refractory acute graft versus host d...[ Price : $8.95]
An FDA safety update indicates that an agency literature review has found reports of 19 squamous cell carcinoma cases in the scar ...[ Price : $8.95]
Federal Register notice: FDA revokes the Emergency Use Authorizations issued for two Covid-19 diagnostics Babson Diagnostics for ...[ Price : $8.95]
FDA will review a BioMarin sBLA to expand the approved achondroplasia treatment indication for Voxzogo to include children under a...