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...
FDA grants breakthrough therapy designations to Alzheimers drugs being developed by Lilly and Eisai/ Biogen.
FDA issues a notice of violation to the Roger Williams Medical Center Oncology Pharmacy Clinic relating to deficiencies in the preparation of compound...