FDA and European Medicines Agency staff describe the benefits seen in their joint Parallel Scientific Advice program.
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...
