Federal Register notice: FDA sends to OMB an information collection revision entitled Time and Extent Applications (TEA) for Nonprescription Drug Prod...
The first two cell-based gene therapies for treating sickle cell disease in patients 12 years and older gain FDA approval Vertex Pharmaceuticals Casg...
Novartis reports updated Kisqali (ribociclib) data from the Phase 3 NATALEE trial that confirms an earlier benefit seen at an interim analysis.
FDA accepts for review an Alpha Cognition NDA for ALPHA-1062 for treating mild-to-moderate Alzheimers disease.
Regeneron says it will submit a BLA to FDA this year for its linvoseltamab multiple myeloma drug based on successful Phase 1/2 trial results.
Reps. Eshoo and McCaul introduce bipartisan legislation to strengthen pediatric drug development.
Zydus Pharmaceuticals asks FDA to take multiple actions against BPI Labs unapproved methylene blue injection product.
Bausch & Lomb asks FDA to impose conditions on any ANDAs for a generic form of its macular edema drug Xipere.
