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.
The agency approves Priovant Therapeutics Lisraya (brepocitinib) tablets for treating dermatomyositis in adults.
Rep. Lauren Boebert introduces legislation to remove some barriers to the development of botanical drugs.
Five stakeholders support an FDA proposal for an expedited IND pilot program and suggest ways to improve it.
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...
Akin Gump attorneys highlight major issues in the PDUFA 8 commitment letter that is now open for public comment.
