FDA accepts an Antag Therapeutics IND for its lead molecule, AT-7687, to begin a Phase 1 clinical trial to evaluate it for treating obesity.
CDRH posts a list of final and draft guidances it expects to publish in FY 2024.
While denying a Parenteral Technologies petition to force a change in pediatric acetaminophen directions for use, FDA says it is planning a safety ord...
The Justice Department says Magellan Diagnostics has been ordered to pay $42 million in fines, forfeitures, and compensation after pleading guilty to ...
FDA approves Genentechs Itovebi to be used with two other drugs to treat some breast cancers identified through a diagnostic test.
FDA approves an IDE for Iota Biosciences to conduct a feasibility study of its investigational implantable device designed to deliver electrical stimu...
Attorneys at Hogan Lovells say (XXX DELETE s XXX)that a final guidance on electronic records and systems used in clinical trials includes a broader sc...
Teva Pharmaceuticals agrees to pay $450 million to resolve two civil cases that allege the company violated the Anti-Kickback Statute and the False Cl...
