The U.S. Court of Federal Claims grants FDA summary judgment on the pleadings and rejects Vandas 5th Amendment taking argument about FDA disclosure of...
The union representing FDA employees sues President Trump over efforts to replace many Civil Service workers with political appointees.
The Trump Administration places a temporary embargo on external communications by FDA and other government health agencies until political appointees ...
FDA removes clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it licensed from Eli Lill...
Patient advocacy group Friends of Cancer Research adds former principal deputy commissioner Janet Woodcock to their board of directors.
FDA grants Life Molecular Imaging a fast track designation to [18F]florbetaben for diagnosing cardiac amyloid light-chain and amyloid transthyretin-re...
Atara Biotherapeutics says it has reached an agreement with FDA on the steps needed to lift agency clinical holds on its Ebvallo and ATA3219.
FDA clears an Inflammatix 510(k) for its TriVerity Test System, which it describes as a first-in-class molecular test for patients with suspected acut...
