FDA issues Alar Pharmaceuticals an untitled letter over promotional materials for its investigational ketamine drug, ALA-3000, because they improperly...
FDAs approval of new drugs is increasingly being supported by fewer clinical studies.
FDA issues an Early Alert after becoming aware that Boston Scientific sent a letter to customers recommending all Imager II Angiographic Catheters be ...
FDA approves Eli Lillys Mounjaro (tirzepatide) for lowering the risk of major adverse cardiovascular events.
FDA approves updated Covid-19 vaccines from Moderna, Pfizer-BioNTech and Novavax/Sanofi for the upcoming vaccination season.
The agency approves Priovant Therapeutics Lisraya (brepocitinib) tablets for treating dermatomyositis in adults.
Akin Gump attorneys highlight major issues in the PDUFA 8 commitment letter that is now open for public comment.
MasterControl issues its 2026 life sciences regulatory readiness playbook demonstrating the significant ways in which the FDA Quality System Managemen...
