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.
Covis Pharma says it is willing to work with CDER on an orderly withdrawal of Makena from the market.
Six Oncology Center of Excellence staff members describe the process used in developing a new patient-focused glossary of cancer clinical trial terms.
The United States Pharmacopeia launches its Nitrosamines Analytical Hub to help address the nitrosamine crisis in the U.S.
