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.
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...
The U.S. Court of Appeals for the Fifth Circuit upholds FDAs decision to remove tirzepatide from the agencys drug shortage list, a ruling that limits ...
Reed Smith attorney James Beck says courts so far have rejected all arguments citing the Supreme Courts Loper Bright decision as a reason to reject pr...
