FDAs seeks a $372 million (10%) boost and a $150 million increase in user fees in its fiscal year 2024 budget proposal.
AstraZeneca says data from its ADAURA Phase 3 trial showed that Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaning...
The Justice Department says the former CEO of Stimwave has been indicted for healthcare fraud in creating and marketing a non-functional medical devic...
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.
