Genus Lifesciences asks the DC federal court to rule that FDA unlawfully approved Lannetts Numbrino during a time when Genus had NCEE exclusivity for ...
FDA warns Wave Miami that it is distributing an unapproved and misbranded new drug containing an undeclared erectile dysfunction drug.
FDA launches a mobile-friendly database with information, including labeling, on antiretroviral drugs approved for use in the PEPFAR program overseas.
Novartis says it is abandoning its development program for a generic copy of GlaxoSmithKlines Advair Diskus (fluticasone propionate/salmeterol).
FDA clears a Sony Electronics 510(k) for its Nucleus Operating Room Imaging Management and Collaboration Control platform.
A California federal judge says an FDA suit against two California stem cell clinics should go to trial to determine whether the agency has regulatory...
A study from Florida Atlantic Universitys Schmidt College of Medicine finds that granulocyte colony-stimulating factor or Amgens Neupogen may offer a ...
Federal Register notice: FDA seeks comments on a proposed study entitled Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion....