Lilly says it is terminating the clinical development of solanezumab for preclinical Alzheimers disease after it failed to meet the primary or seconda...
FDA commissioner Robert Califf says in a Stat News interview that FDA is looking for ways to improve and expand its efforts to combat medical misinfor...
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...
FDA will review a BioMarin sBLA to expand the approved achondroplasia treatment indication for Voxzogo to include children under age 5.
