Avid Medical recalls (Class 1) medical convenience kits that include the BD/Carefusion Chloraprep 3mL applicator due to the risk of contamination with...
FDA publishes a draft guidance to encourage the inclusion of some patients with incurable cancers in trials of new cancer therapies.
Federal Register notice: FDA makes available a final guidance entitled Covid 19: Master Protocols Evaluating Drugs and Biological Products for Treatme...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novartis Zolgensma.
Reps. DeGette and Upton propose language for a Cures 2.0 bill circulating in Congress to create the Advanced Research Projects Agency-Health sought by...
The Oncology Drug Advisory Committee recommends that FDA not take action to approve Incytes retifanlimab for squamous carcinoma of the anal canal and ...
FDA accepts for priority review a Genentech BLA for its Port Delivery System with ranibizumab for treating wet age-related macular degeneration.
Federal Register notice: FDA announces a 9/21 public workshop entitled Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial De...