FDA grants Theriva Biologics an orphan drug designation for VCN-01, a systemic, selective, stroma-degrading oncolytic adenovirus for treating pancreat...
Madrigal Pharmaceuticals begins a rolling NDA submission seeking accelerated approval of resmetirom for treating nonalcoholic steatohepatitis.
Teleflex recalls its Slick Set Uncuffed Endotracheal Tube and Stylet Set (oral/nasal) due to reports about the 15mm connector disconnecting from the e...
Bipartisan House members reintroduce the Promising Pathway Act that would provide a provisional approval pathway for promising drugs.
Federal Register notice: FDA announces an information collection revision entitled New Animal Drugs for Minor Use and Minor Species.
A Bloomberg editorial calls for better FDA regulation and more transparency in dealing with generic drugs and active pharmaceutical ingredients coming...
Federal Register notice: FDA makes available a final guidance entitled Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment.
Federal Register notice: FDA posts a list of eight information collections that have been approved by OMB.
