Athenex decides to abandon its continued development of oral paclitaxel plus encequidar for treating metastatic breast cancer after meeting with FDA t...
FDA grants Y-mAbs Therapeutics a rare pediatric disease designation for the companys lutetium-labeled omburtamab antibody program for treating medullo...
Merck submits an application seeking emergency use authorization for molnupiravir, an investigational oral antiviral medicine that new data show signi...
FDA Review has posted the Federal Register notices for the week ending 10/8/2021.
FDA Review posts product approval summaries for the week ending 10/8/2021.
FDA approves a ChemoCentryx NDA for Tavneos (avacopan) as an add-on treatment for adult patients with severe active anti-neutrophil cytoplasmic autoa...
FDAs Antimicrobial Drugs Advisory Committee votes 17-0 to recommend approval of Takedas maribavir to treat cytomegalovirus infection in the post-trans...